{"product_id":"mdr-regulatory-consultancy","title":"MDR Regulatory Consultancy \u0026 Technical Documentation Service","description":"\u003cp\u003eEaseCert supports medical device manufacturers with the preparation, review, improvement, and organisation of technical documentation under Regulation (EU) 2017\/745 on medical devices.\u003c\/p\u003e\n\u003cp\u003eThis service is intended for manufacturers that require practical support with MDR qualification, classification, technical documentation, risk management, clinical evidence, labelling, post-market surveillance, and regulatory gap remediation.\u003c\/p\u003e\n\u003cp\u003eEaseCert acts solely as an independent regulatory consultant for medical device projects.\u003c\/p\u003e\n\u003ch2\u003eImportant Scope Limitation\u003c\/h2\u003e\n\u003cp\u003eEaseCert does not act as an EU Authorised Representative, European Authorised Representative, EU Responsible Person, Notified Body, competent authority, testing laboratory, importer, distributor, legal adviser, or manufacturer for medical devices.\u003c\/p\u003e\n\u003cp\u003eEaseCert’s standard EU Responsible Person and EU Authorised Representative services for general consumer products and certain CE-marked non-medical products do not extend to medical devices regulated under Regulation (EU) 2017\/745.\u003c\/p\u003e\n\u003cp\u003eMedical device manufacturers established outside the European Union must separately appoint a suitably qualified European Authorised Representative in accordance with the MDR. Where required, the manufacturer must also engage an appropriately designated Notified Body.\u003c\/p\u003e\n\u003cp\u003eEaseCert may coordinate with the manufacturer’s appointed European Authorised Representative, Notified Body, laboratory, clinical expert, toxicologist, or other specialist, but EaseCert does not replace these parties or assume their legal responsibilities.\u003c\/p\u003e\n\u003ch2\u003eService Scope\u003c\/h2\u003e\n\u003ch3\u003e1. Regulatory Strategy and Gap Analysis\u003c\/h3\u003e\n\u003cp\u003eEaseCert reviews the available product information and existing documentation to establish the current regulatory position of the device and identify the work required for MDR compliance.\u003c\/p\u003e\n\u003ch4\u003eTypical activities include:\u003c\/h4\u003e\n\u003cul\u003e\n\u003cli\u003eReview of existing technical, quality, clinical, testing, manufacturing, labelling, and post-market documentation\u003c\/li\u003e\n\u003cli\u003eAssessment of whether the product may qualify as a medical device under the MDR\u003c\/li\u003e\n\u003cli\u003eReview of the proposed intended purpose and medical claims\u003c\/li\u003e\n\u003cli\u003eAssessment of the principal mode of action\u003c\/li\u003e\n\u003cli\u003eReview of the proposed MDR classification and applicable Annex VIII rules\u003c\/li\u003e\n\u003cli\u003eAssessment of whether Notified Body involvement may be required\u003c\/li\u003e\n\u003cli\u003eIdentification of the applicable conformity assessment route\u003c\/li\u003e\n\u003cli\u003eReview of the manufacturer, importer, distributor, and European Authorised Representative roles\u003c\/li\u003e\n\u003cli\u003eIdentification of missing documents, testing, evidence, approvals, and manufacturer decisions\u003c\/li\u003e\n\u003cli\u003ePreparation of a prioritised regulatory gap analysis and action plan\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eThe final qualification, intended purpose, classification, conformity assessment route, and regulatory strategy remain the responsibility of the manufacturer and must be confirmed by the appropriate regulatory parties where necessary.\u003c\/p\u003e\n\u003ch3\u003e2. MDR Technical Documentation Preparation\u003c\/h3\u003e\n\u003cp\u003eEaseCert supports the preparation and improvement of technical documentation in accordance with the structure and principles of MDR Annex II and Annex III.\u003c\/p\u003e\n\u003cp\u003eExisting documentation is reused and adapted wherever appropriate. EaseCert does not create unnecessary documents merely because they appear on a generic checklist.\u003c\/p\u003e\n\u003ch4\u003eDepending on the device and agreed project scope, the documentation may include:\u003c\/h4\u003e\n\u003cul\u003e\n\u003cli\u003eDevice description and specifications\u003c\/li\u003e\n\u003cli\u003eProduct variants and configurations\u003c\/li\u003e\n\u003cli\u003eIntended purpose\u003c\/li\u003e\n\u003cli\u003eIndications, contraindications, intended users, and patient population\u003c\/li\u003e\n\u003cli\u003eMode of action\u003c\/li\u003e\n\u003cli\u003eMedical device qualification rationale\u003c\/li\u003e\n\u003cli\u003eMDR classification rationale\u003c\/li\u003e\n\u003cli\u003eConformity assessment route summary\u003c\/li\u003e\n\u003cli\u003eDesign and manufacturing information\u003c\/li\u003e\n\u003cli\u003eBill of materials or composition review\u003c\/li\u003e\n\u003cli\u003eManufacturing process and process-control documentation review\u003c\/li\u003e\n\u003cli\u003eTechnical specifications and finished-device requirements\u003c\/li\u003e\n\u003cli\u003eGeneral Safety and Performance Requirements checklist\u003c\/li\u003e\n\u003cli\u003eApplicable standards and evidence mapping\u003c\/li\u003e\n\u003cli\u003eVerification and validation summary\u003c\/li\u003e\n\u003cli\u003ePackaging and shelf-life documentation review\u003c\/li\u003e\n\u003cli\u003eClinical evaluation documentation\u003c\/li\u003e\n\u003cli\u003ePost-Market Surveillance documentation\u003c\/li\u003e\n\u003cli\u003ePost-Market Clinical Follow-up documentation or justification, where applicable\u003c\/li\u003e\n\u003cli\u003eLabelling and Instructions for Use review\u003c\/li\u003e\n\u003cli\u003eDraft EU Declaration of Conformity\u003c\/li\u003e\n\u003cli\u003eUDI and registration information review\u003c\/li\u003e\n\u003cli\u003eTechnical documentation index and document-reference matrix\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3\u003e3. Risk Management Documentation\u003c\/h3\u003e\n\u003cp\u003eEaseCert supports the preparation and review of risk management documentation using a device-specific and evidence-based approach.\u003c\/p\u003e\n\u003ch4\u003eRisk management support may include:\u003c\/h4\u003e\n\u003cul\u003e\n\u003cli\u003eRisk Management Plan\u003c\/li\u003e\n\u003cli\u003eHazard identification\u003c\/li\u003e\n\u003cli\u003eHazardous situations and foreseeable sequences of events\u003c\/li\u003e\n\u003cli\u003ePotential harms\u003c\/li\u003e\n\u003cli\u003eRisk estimation and evaluation\u003c\/li\u003e\n\u003cli\u003eRisk control measures\u003c\/li\u003e\n\u003cli\u003eVerification of risk controls\u003c\/li\u003e\n\u003cli\u003eResidual-risk evaluation\u003c\/li\u003e\n\u003cli\u003eBenefit-risk analysis, where required\u003c\/li\u003e\n\u003cli\u003eProduction and post-production information\u003c\/li\u003e\n\u003cli\u003eRisk Management Report\u003c\/li\u003e\n\u003cli\u003eAlignment of risks with labelling, clinical evaluation, testing, and post-market surveillance\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eEaseCert does not invent numerical risk ratings, acceptance criteria, testing results, or risk-control verification. Where the manufacturer does not have an approved risk matrix or sufficient supporting evidence, this will be clearly identified as an open point.\u003c\/p\u003e\n\u003ch3\u003e4. General Safety and Performance Requirements\u003c\/h3\u003e\n\u003cp\u003eEaseCert prepares or reviews the General Safety and Performance Requirements checklist in a proportionate manner based on the device characteristics, intended purpose, risks, materials, performance claims, and conformity assessment route.\u003c\/p\u003e\n\u003ch4\u003eThe review may cover:\u003c\/h4\u003e\n\u003cul\u003e\n\u003cli\u003eApplicability of each relevant requirement\u003c\/li\u003e\n\u003cli\u003eJustification for non-applicable requirements\u003c\/li\u003e\n\u003cli\u003eMethods used to demonstrate conformity\u003c\/li\u003e\n\u003cli\u003eApplicable standards or alternative methods\u003c\/li\u003e\n\u003cli\u003eSupporting evidence references\u003c\/li\u003e\n\u003cli\u003eOutstanding evidence or documentation gaps\u003c\/li\u003e\n\u003cli\u003eConsistency with the Risk Management File and technical documentation\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eStandards are only referenced where they have actually been applied, are proposed as a compliance method, or are otherwise relevant to the state of the art.\u003c\/p\u003e\n\u003ch3\u003e5. Verification, Validation, and Testing Review\u003c\/h3\u003e\n\u003cp\u003eEaseCert reviews available testing and technical evidence to assess whether it supports the finished commercial device, its intended purpose, safety, performance, risks, claims, shelf life, packaging, and labelling.\u003c\/p\u003e\n\u003ch4\u003eThis may include review of:\u003c\/h4\u003e\n\u003cul\u003e\n\u003cli\u003ePerformance testing\u003c\/li\u003e\n\u003cli\u003eBiological evaluation\u003c\/li\u003e\n\u003cli\u003eChemical characterisation\u003c\/li\u003e\n\u003cli\u003eBiocompatibility testing\u003c\/li\u003e\n\u003cli\u003eElectrical safety and electromagnetic compatibility\u003c\/li\u003e\n\u003cli\u003eSoftware verification and validation\u003c\/li\u003e\n\u003cli\u003eUsability engineering\u003c\/li\u003e\n\u003cli\u003eMicrobiological testing\u003c\/li\u003e\n\u003cli\u003eSterilisation validation\u003c\/li\u003e\n\u003cli\u003eCleaning and disinfection validation\u003c\/li\u003e\n\u003cli\u003ePackaging validation\u003c\/li\u003e\n\u003cli\u003eTransport testing\u003c\/li\u003e\n\u003cli\u003eStability and shelf-life evidence\u003c\/li\u003e\n\u003cli\u003eMechanical testing\u003c\/li\u003e\n\u003cli\u003eMaterial specifications\u003c\/li\u003e\n\u003cli\u003eSupplier declarations and certificates\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eEaseCert does not conduct laboratory testing and does not issue test reports. Where testing is required, EaseCert may help define the regulatory objective, review laboratory quotations or protocols, and assess the resulting documentation.\u003c\/p\u003e\n\u003ch3\u003e6. Clinical Evaluation Support\u003c\/h3\u003e\n\u003cp\u003eEaseCert supports the preparation, review, and improvement of clinical evaluation documentation based on the available evidence and the intended purpose of the device.\u003c\/p\u003e\n\u003ch4\u003eClinical evaluation support may include:\u003c\/h4\u003e\n\u003cul\u003e\n\u003cli\u003eClinical Evaluation Plan\u003c\/li\u003e\n\u003cli\u003eClinical evidence strategy\u003c\/li\u003e\n\u003cli\u003eState-of-the-art review\u003c\/li\u003e\n\u003cli\u003eLiterature search strategy\u003c\/li\u003e\n\u003cli\u003eLiterature appraisal structure\u003c\/li\u003e\n\u003cli\u003eClinical data review\u003c\/li\u003e\n\u003cli\u003eAssessment of clinical safety and performance\u003c\/li\u003e\n\u003cli\u003eAssessment of clinical benefits\u003c\/li\u003e\n\u003cli\u003eBenefit-risk consistency review\u003c\/li\u003e\n\u003cli\u003eClinical Evaluation Report drafting support\u003c\/li\u003e\n\u003cli\u003eEvaluation of whether additional clinical evidence may be required\u003c\/li\u003e\n\u003cli\u003ePMCF assessment or justification\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eEaseCert does not act as a clinician or automatically provide the qualifications required for every type of clinical evaluation. Where specialist medical, scientific, toxicological, biological, statistical, or clinical expertise is required, this must be provided or approved by an appropriately qualified person.\u003c\/p\u003e\n\u003cp\u003eEaseCert does not invent clinical data, claim equivalence without sufficient evidence, or confirm that a clinical investigation is unnecessary without an adequate device-specific justification.\u003c\/p\u003e\n\u003ch3\u003e7. Labelling and Instructions for Use Review\u003c\/h3\u003e\n\u003cp\u003eEaseCert reviews medical device labels, packaging, Instructions for Use, symbols, websites, and marketing claims for consistency with the technical documentation and the applicable MDR requirements.\u003c\/p\u003e\n\u003ch4\u003eThe review may include:\u003c\/h4\u003e\n\u003cul\u003e\n\u003cli\u003eDevice identification\u003c\/li\u003e\n\u003cli\u003eManufacturer details\u003c\/li\u003e\n\u003cli\u003eEuropean Authorised Representative details\u003c\/li\u003e\n\u003cli\u003eCE marking\u003c\/li\u003e\n\u003cli\u003eNotified Body number, where applicable\u003c\/li\u003e\n\u003cli\u003eUDI information\u003c\/li\u003e\n\u003cli\u003eLot, batch, or serial identification\u003c\/li\u003e\n\u003cli\u003eManufacturing and expiry information\u003c\/li\u003e\n\u003cli\u003eStorage and transport conditions\u003c\/li\u003e\n\u003cli\u003eIntended purpose\u003c\/li\u003e\n\u003cli\u003eIndications and contraindications\u003c\/li\u003e\n\u003cli\u003eWarnings and precautions\u003c\/li\u003e\n\u003cli\u003eResidual-risk communication\u003c\/li\u003e\n\u003cli\u003eApplicable symbols\u003c\/li\u003e\n\u003cli\u003eLanguage requirements\u003c\/li\u003e\n\u003cli\u003eSerious-incident reporting information\u003c\/li\u003e\n\u003cli\u003eConsistency of claims across labels, websites, and technical documentation\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eEaseCert does not approve unsupported medical claims or broaden the intended purpose beyond the available evidence.\u003c\/p\u003e\n\u003ch3\u003e8. Post-Market Surveillance and PMCF\u003c\/h3\u003e\n\u003cp\u003eEaseCert supports the preparation of proportionate Post-Market Surveillance documentation based on the device class, risks, market history, intended users, and available clinical evidence.\u003c\/p\u003e\n\u003ch4\u003eThis may include:\u003c\/h4\u003e\n\u003cul\u003e\n\u003cli\u003ePost-Market Surveillance Plan\u003c\/li\u003e\n\u003cli\u003ePost-Market Surveillance Report\u003c\/li\u003e\n\u003cli\u003ePeriodic Safety Update Report structure, where applicable\u003c\/li\u003e\n\u003cli\u003eComplaint-data review structure\u003c\/li\u003e\n\u003cli\u003eIncident and vigilance-data review\u003c\/li\u003e\n\u003cli\u003eTrend-reporting considerations\u003c\/li\u003e\n\u003cli\u003eLiterature-monitoring activities\u003c\/li\u003e\n\u003cli\u003eUser and distributor feedback collection\u003c\/li\u003e\n\u003cli\u003eCorrective and preventive action interfaces\u003c\/li\u003e\n\u003cli\u003ePMCF Plan\u003c\/li\u003e\n\u003cli\u003ePMCF Evaluation Report\u003c\/li\u003e\n\u003cli\u003eDevice-specific PMCF justification\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eEaseCert does not populate post-market documentation with invented sales, complaint, incident, return, trend, or corrective-action data.\u003c\/p\u003e\n\u003ch3\u003e9. EU Declaration of Conformity, UDI, and Registration Support\u003c\/h3\u003e\n\u003cp\u003eEaseCert may prepare draft documentation and review available information relating to the EU Declaration of Conformity, UDI structure, CE marking, manufacturer registration, device registration, and European Authorised Representative information.\u003c\/p\u003e\n\u003ch4\u003eSupport may include:\u003c\/h4\u003e\n\u003cul\u003e\n\u003cli\u003eDraft EU Declaration of Conformity\u003c\/li\u003e\n\u003cli\u003eReview of applicable legislation and standards listed in the declaration\u003c\/li\u003e\n\u003cli\u003eReview of device identification and classification information\u003c\/li\u003e\n\u003cli\u003eReview of Basic UDI-DI and UDI structure information supplied by the manufacturer\u003c\/li\u003e\n\u003cli\u003eReview of CE-marking information\u003c\/li\u003e\n\u003cli\u003eReview of European Authorised Representative details\u003c\/li\u003e\n\u003cli\u003eReview of available registration records\u003c\/li\u003e\n\u003cli\u003eConsistency review between the declaration, labels, technical file, and registration information\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eEaseCert does not assign official UDI values, issue SRNs, register the manufacturer as its European Authorised Representative, apply the CE marking on behalf of the manufacturer, or sign the EU Declaration of Conformity.\u003c\/p\u003e\n\u003cp\u003eThe final declaration must be reviewed, approved, and signed by the legal manufacturer.\u003c\/p\u003e\n\u003ch3\u003e10. Regulatory Review and Coordination Support\u003c\/h3\u003e\n\u003cp\u003eEaseCert may support communication and document coordination between the manufacturer and relevant third parties.\u003c\/p\u003e\n\u003ch4\u003eThis may include coordination with:\u003c\/h4\u003e\n\u003cul\u003e\n\u003cli\u003eThe manufacturer’s appointed European Authorised Representative\u003c\/li\u003e\n\u003cli\u003eNotified Bodies\u003c\/li\u003e\n\u003cli\u003eTesting laboratories\u003c\/li\u003e\n\u003cli\u003eContract manufacturers\u003c\/li\u003e\n\u003cli\u003eCritical suppliers\u003c\/li\u003e\n\u003cli\u003eClinical experts\u003c\/li\u003e\n\u003cli\u003eToxicologists\u003c\/li\u003e\n\u003cli\u003eBiological safety specialists\u003c\/li\u003e\n\u003cli\u003eRegulatory reviewers\u003c\/li\u003e\n\u003cli\u003eCompetent authorities, where agreed and appropriate\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eEaseCert may prepare draft responses, evidence summaries, action lists, and document packages. Any formal submission, legal representation, authority notification, or regulated communication must be made or approved by the responsible manufacturer, European Authorised Representative, Notified Body, or other legally authorised party.\u003c\/p\u003e\n\u003ch2\u003eDeliverables\u003c\/h2\u003e\n\u003cp\u003eThe exact deliverables depend on the device, risk class, available evidence, existing documentation, conformity assessment route, and agreed commercial scope.\u003c\/p\u003e\n\u003ch3\u003ePossible deliverables include:\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eMDR regulatory gap analysis\u003c\/li\u003e\n\u003cli\u003eQualification and classification rationale\u003c\/li\u003e\n\u003cli\u003eTechnical Documentation under Annex II and Annex III\u003c\/li\u003e\n\u003cli\u003eRisk Management File\u003c\/li\u003e\n\u003cli\u003eGSPR checklist\u003c\/li\u003e\n\u003cli\u003eVerification and validation evidence matrix\u003c\/li\u003e\n\u003cli\u003eClinical Evaluation Plan\u003c\/li\u003e\n\u003cli\u003eClinical Evaluation Report\u003c\/li\u003e\n\u003cli\u003ePost-Market Surveillance Plan\u003c\/li\u003e\n\u003cli\u003ePMCF Plan or justification\u003c\/li\u003e\n\u003cli\u003eLabelling and IFU review report\u003c\/li\u003e\n\u003cli\u003eDraft EU Declaration of Conformity\u003c\/li\u003e\n\u003cli\u003eTechnical documentation index\u003c\/li\u003e\n\u003cli\u003eOpen-point and action tracker\u003c\/li\u003e\n\u003cli\u003eRegulatory submission support package\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eManufacturer Responsibilities\u003c\/h2\u003e\n\u003cp\u003eThe manufacturer remains legally responsible for compliance with Regulation (EU) 2017\/745.\u003c\/p\u003e\n\u003ch3\u003eThe manufacturer is responsible for:\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eConfirming the legal manufacturer identity\u003c\/li\u003e\n\u003cli\u003eApproving the intended purpose and product claims\u003c\/li\u003e\n\u003cli\u003eConfirming the device qualification and classification\u003c\/li\u003e\n\u003cli\u003eSelecting and completing the appropriate conformity assessment route\u003c\/li\u003e\n\u003cli\u003eAppointing a European Authorised Representative where required\u003c\/li\u003e\n\u003cli\u003eEngaging a Notified Body where required\u003c\/li\u003e\n\u003cli\u003eProviding complete and accurate technical information\u003c\/li\u003e\n\u003cli\u003eProviding manufacturing, supplier, material, formulation, and specification information\u003c\/li\u003e\n\u003cli\u003eEnsuring test samples represent the finished commercial device\u003c\/li\u003e\n\u003cli\u003eApproving risk-acceptability criteria\u003c\/li\u003e\n\u003cli\u003eEnsuring the availability of adequate clinical evidence\u003c\/li\u003e\n\u003cli\u003eImplementing the quality management system\u003c\/li\u003e\n\u003cli\u003eImplementing post-market surveillance and vigilance systems\u003c\/li\u003e\n\u003cli\u003eAssigning UDI information\u003c\/li\u003e\n\u003cli\u003eCompleting applicable registrations\u003c\/li\u003e\n\u003cli\u003ePreparing, approving, and signing the EU Declaration of Conformity\u003c\/li\u003e\n\u003cli\u003eApplying the CE marking\u003c\/li\u003e\n\u003cli\u003eMaintaining and updating the technical documentation\u003c\/li\u003e\n\u003cli\u003eAssessing product, supplier, manufacturing, labelling, and regulatory changes\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eInformation Required from the Client\u003c\/h2\u003e\n\u003ch3\u003eTypical project information includes:\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eProduct description and photographs\u003c\/li\u003e\n\u003cli\u003eIntended purpose and medical claims\u003c\/li\u003e\n\u003cli\u003eTarget patient population and intended users\u003c\/li\u003e\n\u003cli\u003eProduct specifications\u003c\/li\u003e\n\u003cli\u003eProduct variants and configurations\u003c\/li\u003e\n\u003cli\u003eBill of materials or formulation\u003c\/li\u003e\n\u003cli\u003eMaterial and ingredient specifications\u003c\/li\u003e\n\u003cli\u003eManufacturing process information\u003c\/li\u003e\n\u003cli\u003eSupplier and contract manufacturer information\u003c\/li\u003e\n\u003cli\u003eExisting risk assessments\u003c\/li\u003e\n\u003cli\u003eTest reports and validation reports\u003c\/li\u003e\n\u003cli\u003eClinical evidence and literature\u003c\/li\u003e\n\u003cli\u003eExisting labels, packaging, and Instructions for Use\u003c\/li\u003e\n\u003cli\u003eComplaint, incident, return, and post-market information\u003c\/li\u003e\n\u003cli\u003eExisting quality-system procedures\u003c\/li\u003e\n\u003cli\u003ePrevious declarations, certificates, or registrations\u003c\/li\u003e\n\u003cli\u003eEuropean Authorised Representative information, where appointed\u003c\/li\u003e\n\u003cli\u003eNotified Body correspondence, where applicable\u003c\/li\u003e\n\u003cli\u003eAuthority or regulatory correspondence, where applicable\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eExclusions\u003c\/h2\u003e\n\u003ch3\u003eUnless separately agreed, the service does not include:\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eActing as the European Authorised Representative for a medical device manufacturer\u003c\/li\u003e\n\u003cli\u003eActing as an EU Responsible Person for medical devices\u003c\/li\u003e\n\u003cli\u003eActing as an importer or distributor\u003c\/li\u003e\n\u003cli\u003eNotified Body conformity assessment or certification\u003c\/li\u003e\n\u003cli\u003eIssuing CE certificates\u003c\/li\u003e\n\u003cli\u003eLaboratory testing\u003c\/li\u003e\n\u003cli\u003eClinical investigations\u003c\/li\u003e\n\u003cli\u003eMedical or clinical opinions\u003c\/li\u003e\n\u003cli\u003eToxicological assessments requiring a qualified toxicologist\u003c\/li\u003e\n\u003cli\u003eBiological safety assessments requiring specialist qualifications\u003c\/li\u003e\n\u003cli\u003eLegal advice\u003c\/li\u003e\n\u003cli\u003ePatent or intellectual-property advice\u003c\/li\u003e\n\u003cli\u003eQuality management system certification\u003c\/li\u003e\n\u003cli\u003eISO 13485 certification\u003c\/li\u003e\n\u003cli\u003eOfficial UDI assignment\u003c\/li\u003e\n\u003cli\u003eOfficial EUDAMED, national database, or authority registration unless expressly included as administrative assistance\u003c\/li\u003e\n\u003cli\u003eSigning documents on behalf of the manufacturer\u003c\/li\u003e\n\u003cli\u003eGuaranteeing approval, certification, CE marking, registration, or market acceptance\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eOur Approach\u003c\/h2\u003e\n\u003cp\u003eEaseCert follows a proportionate, evidence-based, and practical approach.\u003c\/p\u003e\n\u003ch3\u003eOur objective is to:\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eReuse suitable existing documentation\u003c\/li\u003e\n\u003cli\u003eAvoid unnecessary duplication\u003c\/li\u003e\n\u003cli\u003eIdentify critical regulatory gaps early\u003c\/li\u003e\n\u003cli\u003eKeep the intended purpose, classification, risks, clinical evidence, testing, labelling, and post-market documentation consistent\u003c\/li\u003e\n\u003cli\u003eClearly distinguish confirmed facts from assumptions and open points\u003c\/li\u003e\n\u003cli\u003ePrepare documents in a structure suitable for manufacturer, European Authorised Representative, or Notified Body review\u003c\/li\u003e\n\u003cli\u003eProduce the smallest complete and legally sufficient technical documentation package appropriate for the device\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eNo technical, clinical, manufacturing, registration, testing, or compliance information will be invented. Missing evidence will be clearly identified, together with the party responsible for supplying or approving it.\u003c\/p\u003e\n\u003ch2\u003eProject Structure and Pricing\u003c\/h2\u003e\n\u003cp\u003eMDR consultancy projects are quoted individually because the workload depends heavily on the device classification, complexity, intended purpose, available documentation, quality of the existing evidence, applicable standards, clinical requirements, and conformity assessment route.\u003c\/p\u003e\n\u003ch3\u003eProjects may be offered as:\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eFixed-scope regulatory gap assessments\u003c\/li\u003e\n\u003cli\u003eHourly regulatory consultancy\u003c\/li\u003e\n\u003cli\u003eTechnical documentation preparation packages\u003c\/li\u003e\n\u003cli\u003eDocument remediation projects\u003c\/li\u003e\n\u003cli\u003eClinical evaluation support packages\u003c\/li\u003e\n\u003cli\u003eRisk management and GSPR preparation packages\u003c\/li\u003e\n\u003cli\u003eOngoing coordination with the appointed European Authorised Representative or Notified Body\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eAny testing, laboratory work, specialist assessment, Notified Body fees, European Authorised Representative fees, registration charges, translation costs, or third-party expenses are separate unless expressly included in the quotation.\u003c\/p\u003e","brand":"EaseCert | GPSR Compliance","offers":[{"title":"Default Title","offer_id":50806621012197,"sku":"MDR-CONSULTANCY","price":2000.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0731\/2565\/8853\/files\/MDRRegulatoryConsultancy_TechnicalDocumentationService.heic?v=1785113260","url":"https:\/\/easecert.com\/products\/mdr-regulatory-consultancy","provider":"EaseCert | GPSR Compliance","version":"1.0","type":"link"}