When setting up and monitoring a quality management system for medical devices, Metecon provides support in preparing for audits and inspections, assists in adapting to changing requirements, audits manufacturing processes and much more.Test our skills, we are looking forward to your project!
QMS for international approvalsPlacing medical devices and IVDs on the market in international target markets is one of our core competencies, in addition to the implementation of the QMS according to ISO 13485 in conjunction with the European requirements from MDR and IVDR.
This includes the international requirements according to:
- USA target market: 21 CFR 820 Quality System Regulation (expected to be in force until December 2023),
- Other target markets:
- Canadian Medical Devices Regulation (CMDR): CAN/CSA ISO 13485 (CMDCAS),, Canada,
- Japanese Pharmaceutical Affairs Law (PAL) and J-GMP, Japan,
- Brazil Medical Devices Regulation (ANVISA/INMETRO), Brazil,
- Therapeutic Goods Administration (TGA), Australia.
- Target market Switzerland: 812.213 Medical Devices Regulation (MepV)
- Target market UK: UK MDR 2002
What about the FDA regulation for QMS?The QMSR (Quality Management System Regulation) replaces the QSR (Quality System Regulation). This means that the QSR will be harmonized with ISO 13485.
Find out what this means for you as a manufacturer here.
Placing medical devices in the UK marketThe current post-Brexit regulatory framework for medical devices in the UK is provided by the UK MDR 2002. This regulatory framework combines Directive 93/42/EEC on medical devices (EU MDD), Directive 90/385/EEC on active implantable medical devices (EU AIMDD) and Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD); medical devices are placed on the market in the UK according to these requirements.
We are happy to support you here with the following issues:
- Implementation of the regulatory requirements for access to the target market UK according to UK MDR 2002
- Support in the preparation of the designation letter for your designated UK-REP
- Support in the preparation of the technical documentation for the target market UK
- Support in the correct labeling of your products for the UK market.
Placing medical devices in Switzerland MarketThe aim of the EU Medical Device Regulation (EU MDR) is to provide a uniform basis for placing medical devices on the market in the EU and for their regulation. Brexit already demanded an additional level of regulation from medical device manufacturers; Switzerland is now making market access more difficult as well: as of May 26, 2021, when the EU MDR comes into force, the Mutual Recognition Agreement (MRA) has not been extended, and the Medical Devices Ordinance (MepV) of July 1, 2020, established its own framework for market access in Switzerland. Do you have these framework conditions in mind?
We would be happy to support you here with the following questions:
- Implementation of the regulatory requirements for access to the Swiss target market according to MepV,
- Supplementing your QMS processes with the regulatory requirements of the MepV,
- Support in the preparation of the designation letter for your designated CH-REP,
- Definition of the regulatory requirements of the individual roles of the economic operators.
Our services in detail
- Establish, maintain and service quality management systems and quality management manuals (QMH) including procedural and work instructions as well as corresponding forms,
- Analysis and further development of quality key figures related to customers, suppliers, and production as well as creation of meaningful reporting,
- Introduce and establish quality management (QM) tools,
- trainings and skills transfer in terms of:
- Quality control systems,
- Statistical methods,
- Framework contracts/Quality Agreements,
- Complaint Handling
- Introduction of a CAPA process (Corrective and Preventive Action), incl. the interfaces,
- Medical Device Vigilance/Recall,
- Suppliers for medical device manufacturers:
- Supplier selection
- Supplier audits,
- Supplier evaluation.
- Quality Assurance Agreement (QAA) - advice on the need for a QAA including content and structure,
- Preparation of the required procedures by the MDR: Risk Management, Clinical Evaluation, Post-Market Surveillance and Trend Analysis.
- Quality Management Representative - Interim QMB according to EN ISO 13485