for medical devices and quality management systems
Safety representative according to § 30MPG/ Responsible Person according to Article 15 MDR
- Provision of relevant services accordingly
Consultancy
- Quality management in general and for medical devices in particular
- Implementation and application of quality management systems
- Conformity assessment procedures according to medical device directive
- Embedding of subcontractors and suppliers including OEM/OBL
- Consultancy in new MDR. Preparation of action plans for adapting to new MDR
- Preparation of required documents for MDR and implementation in the qms
- Supporting in changes of technical files to new MDR
- Device Listings with FDA
- Premarket Notifications (510(k)) with FDA
- Communication with FDA
- Official Correspondent for FDA on request
- Gap Analysis QM Systems against MDSAP and 21CFR 820
- Applications with Health Canada
Training
- For all above mentioned topics
Document processing
- Review of existing QM systems
- Preparation or adaptation of a QM system according to MDR
- Adaptation or creation of QM systems according to MDSAP
- Compilation of complete 510 (k) filings
- Conversion of QM systems from DIN EN ISO 13485:2012 to DIN EN ISO 13485:2016
- Conversion of QM systems to DIN EN ISO 9001:2015
- Review of technical documentation
- Quality assurance agreements/contracts between manufacturers and OEM suppliers or subcontractors
- Preparation of contracts according to Article 16 MDR
- Preparation of records
- Processing of deviations from audits or evaluation of technical documentation
- Processing of validation reports on manufacturing processes and sterilization procedures
Contract audits worldwide
- Audits at suppliers
- Audits at subcontractors
- Internal audits
Excerpt of provided services:
