IAuditor Services: 

• • 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)
  • Verification of technical documentation for compliance with requirements MDD and MDR (Medical Device Regulation 2017/745)
  • Establish and implementation of quality management systems for notified bodies (procedures, forms, accreditation rules)

• • 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).

• • European Representative for companies from outside the European Union.

• • Subcontracting as external Lead Auditor for medical device certification bodies (after fulfilling the procedure of independence)

• • 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

• • Detailed classification of medical devices, borderline devices.

• • A comprehensive training programme for manufacturers of medical devices.

• • Service questions and answers for problems related to medical devices. 

• • 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).
  • Representation of the client before competent authorities.

(We speak Polish, English and Russian)