Overview

IAuditor Services: 1. European Union, USA, Canada legal assistance for medical devices, legal regulations MDD, MDR, MDSAP, documentation preparation, completion, approval/clarifications/registration (CE mark, 510 (k), MDSAP) 2. Verification of technical documentation for compliance with requirements MDD and MDR (Medical Device Regulation 2017/745) 3. Establish and implementation of quality management systems for notified bodies (procedures, forms, accreditation rules) 4. Establish and implementation of quality management systems for medical devices manufacturers according to EN 13485 (ISO 9001), MDD (93/42/EEC) and MDR (2017/745) (Validation of software design process EN 62304, validation of ethylene oxide sterilisation processes EN 11135-1, validation of radiation sterilisation process EN 11137-1). 5. European Representative for companies from outside the European Union. 6. Subcontracting as external Lead Auditor for medical device certification bodies (after fulfilling the procedure of independence) 7. Identification and interpretation of documents containing guidelines for medical devices (MDD directive, MDR regulation, MedDev-s, NBOG-S, IAF-s) Identifying and interpreting medical device standards 8. Detailed classification of medical devices, borderline devices. 9. A comprehensive training programme for manufacturers of medical devices. 10. Service questions and answers for problems related to medical devices. 11. Internal and external audits of quality management systems (other parties) in accordance with the requirements of ISO 9001, EN 13485 and MDD (technical documentation reviews). 12. Representation of the client before competent authorities.