Quality Management Systems (QMS) and Product Services:
The best Quality Management System (QMS) is of no use if it does not support the daily business and thus receives acceptance. The ability to adapt to continuously more demanding regulatory or customer requirements determines whether a QMS is sustainably and beneficially established in the company.
Assured and lean compliance saves time, costs and thus resources!
We support in the conception, development, maintenance and also remediation of QMS.
Our specialists support manufacturers of medical devices navigate through the multitude of regulations when placing products on the markets worldwide to comply with national and international regulations and standards.
Services for the medical device and pharmaceutical device industry:
Quality management systems (setup and remediation)
- ISO13485 (MDSAP)
- 21CFR820 (FDA)
- Interim Quality Management
Regulatory intelligence/strategy (approvals)
- Design Dossier
- Design History File (DHF), Device Master Record (DMR)
- Interim Manager Regulatory Affairs
Evidence of the safety and performance of medical devices
- Medical Device Regulation (MDR) / Regulation (EU) 2017/745
- In Vitro Diagnostic Medical Device Regulation (IVDR) / Regulation (EU) 2017/746
- IEC 60601 series of standards
Services for the medical device and pharmaceutical device industry:
- Design Transfer
- Customer and Supplier Management / Supply Chain Optimization
- Project Management
- Preparation and Revision of Documentation
- Change Management / CAPA Management
- Internal Supplier and MDSAP Audits
- Qualification and Validation (including Computer System Validation (CSV))
- Risk Management and Usability (ISO 14971 / IEC 62366)
- Business Analysis / Process Optimization / Production Relocation / Automation
The proof of our core competences are numerous successfully executed projects (set-up, remediation, operations)