Medical Devices Support

Clinres Farmacija offers a comprehensive set of medical device related services. As diverse this field may be, so are our service packages to fit your requirements:

• Gap analysis MDD/IVDD vs MDR/IVDR
• Labeling of medical device (EU, USA, rest of the world)
• Unique Device Identification (UDI): implementation, entrance in databases (e.g. FDA GUIDID)
• Technical documentation according to MDR/IVDR
• Common Submission Dossier Template (cSDT) – summary of technical documentation required for registrations in ASEAN countries
• Table of Content (ToC) format of registration application
• Classification of MDs/IVDs in various jurisdictions (EU, USA, CA, AU, ASEAN…)
• Software standards and regulations: IEC62304; Software as Medical Device (SaMD) – classification, clinical evidence.
• Evaluation of product changes, defining significant changes, change notifications to the authorities worldwide
• Clinical (Performance) Evaluation and Reports
• Medical device single audit program (MDSAP)
• Preparation of registration applications (US 510(k), ASEAN countries, Latin American countries)
• Vigilance of medical devices (EU, USA, AU, BR, CA, APAC countries): preparation of SOPs, assistance in reporting
• Post-market surveillance (PMS) according to MDR/IVDR: SOP, template for PMS plan and report; Post-market clinical follow-up (PMCF) and Post-market performance follow-up (PMPF) plan and report
• Risk management according to ISO 14971
• Design control according to 21 CFR 820.30.