Come along on the journey and learn more about Metecon's services in detail.

Our Services in More Detail:

Regulatory Compliance – From Concept to End of Life

Technical Documentation

Gap analysis, guidance, creation and maintenance of MDR-/IVDR-/FDA compliant technical documentation, development support, TD hosting

Risk Management

Preliminary hazard analysis, product and process related risk analysis, implementation support for risk control, risk management file for MD/IVD

Usability Engineering

Usability engineering process, user needs and use case definition, formative & summative evaluation, human factors engineering for MD/IVD

Mechanical & Electrical Safety

Interpretation and realization support for safety standards (60601, 61010,… family) test organization and/or support with certified test laboratories

Biological Safety

Biological evaluation plan (BEP), support with certified test laboratories, toxicological risk assessment (TRA), biological evaluation report (BER)

Material Compliance

Gap analysis, creation and maintenance of documentation related to RoHS, REACH or other requirements, support on supply chain management

Clinical Affairs & IVD

Clinical/IVD strategy, clinical/performance evaluation plan, SOTA & litera-ture search/analysis, clinical/performance evaluation report, PMCF/PMPF

Medical Software

Gap analysis, software lifecycle processes support, software document-tation, software architecture review, Medical Apps, Health SW, DiGA/DiPA

Cybersecurity

Gap analysis, secure software lifecycle processes support, threat analysis, security risk management, security testing support (threat mitigation, …)

Verification & Validation

Test strategy & planning, requirements & test management, traceability,
test organization (internal/certified test labs), documentation & evaluation

Regulatory Affairs

Market approval strategy, international approvals & registration for EU, MDSAP, ROW, support in QMS compliance, market access support

Post-Market Surveillance

Post market surveillance strategy, creation and maintenance of PMS-Plan, PMS-Report, PSUR, data collection, trend analysis, vigilance support

Digitalization

Digitization strategy, DigiLab, process & implementation support, software validation (CSV), data transfer/migration & maintenance

Quality Management

QMS implementation & maintenance (MDR, IVDR, ISO 13485, Q(M)SR, GxP, ISO 9001, etc.), audit preparation, training & support, internal audits

Medtech AI

Company AI strategy, adaption of software lifecycle processes to artificial intelligence, data management support for training & evaluation

Strategic Consulting

Regulatory approval & compliance related strategy consulting, Integrated Management Systems (IMS), regulatory due diligence for investors

Regulatory Roles

Person responsible for regulatory compliance (PRRC) under MDR/IVDR, CH-REP and EC-REP services, legal manufacturer services (CEyoo)

Metecon Academy

Customer specific workshops, trainings, webinars, knowledge transfer