Services

MTC provides services for the Medical Device Industry

• Regulatory advice on all relevant issues related to CE-marking of medical devices.
• Advice on compliance with the actual status of the EU Medical Devices Regulation Proposal.
• Advice on all national regulatory issues in Germany, Austria and Switzerland (notification, incident reporting, safety officer etc.)
• Liaison with Notified Bodies and Competent Authorities.
• Classification of medical devices and drug/device borderline issues.
• Writing reports on drug device demarcation issues (position papers).
• Working with manufacturers and Competent Authorities on drug device combinations
• Translation of documents into German language (IfU, letters and documents for national authorities).
• Compilation of technical files (design dossiers), consultation files, MDD essential requirements checklists and risk management reports according to EN ISO 14971.
• Preparation of clinical trial files for submission to ethics committees and competent authorities.
• Preparation of final reports of clinical investigations.
• Preparation of clinical evaluation reports based on literature according to MDD, Meddev 2.7.1 and Meddev 2.12-2.
• Writing scientific reports.
• Conduct of clinical study audits.
• Negotiating with Notified Bodies regarding expedited CE-Certifications.
• Advice on manufacturing processes, qualification and validation.
• Advice on installation and implementation of Quality Systems.
• Gap analysis, mock audits and preparation audits of Quality Systems required in Europe and by FDA.
• Supplier audits checking compliance with Quality System and regulatory requirements.
• Due Diligence audits of Quality System, regulatory and technical compliance in context with company mergers, acquisitions of whole companies or subsidiary divisions, venture capital investments or just synergistic co-operation agreements.
• Establishing contacts between manufacturers, suppliers and distributors.