EN ISO 13485 - QMS

The international requirements for quality management in the context of CE-marking are outlined in the standard EN ISO 13485 and include the specifications for compliant development, production, distribution and maintenance of medical devices within an appropriate quality management system.

  • CE plus assists your company to overcome the comprehensive challenges during the entire process of suiting an adequate quality management system to your company complying with the requirements according to the international standard EN ISO 13485.

The synopsis of various international standards and integration of those standards in your internal QM-system lie within the scope of our specialization as well as the development of an appropriate documentation system.

  • CE is experienced and supports for building up an integrated Quality Management System based on EN ISO 13485 but also reflecting 21 CFR Part 820 or further QMS requirements

Auditing support

With new regulations MDR (2017/745) and IVDR (2017/746) requirements will increase significantly - amongst others the control of supply chain and economic operators is one main focus. This will include higher efforts and levels of qualifications and monitoring which often will result in higher need for on-site audits.

CEplus is able – in co-operation with our worldwide located regulanet™ network partners - to support your auditing and monitoring in a strategic and operative way

  • Supplier Qualification (e.g. development or manufacturing subcontractors, raw material suppliers or critical service providers),
  • Maintenance / compliance of implemented Quality Management Systems as well as supplier and distributor monitoring
  • Preparation and implementation of MDSAP requirements (see below)
  • Performance of mock audits against ISO 13485, QSR (21 CFR Part 820) and MDSAP

MDSAP

Based on an initiative of International Medical Device Regulators Forum (IMDRF) the Medical Device Single Audit Program (MDSAP) has been established as global program which allows verification of multiple regulatory jurisdictions within a single audit of a medical device manufacturer’s QMS. The MDSAP program uses ISO 13485:2016 as the common framework, adding country-specific regulatory requirements. MDSAP audits can be performed by recognized MDSAP Auditing Organisations which includes several Notified Bodies. Currently, the MDSAP approach is supported by five countries: Australia, Brazil, Canada, Japan and the United States. The EU is still acting as an observer only.

The participating regulatory authorities hope to achieve more consistency among the auditing organisations. Even though the effort of a MDSAP audit should not be underestimated this approach hopefully leads to an overall reduction of inspection time for medical device manufacturers.

CEplus provides the relevant support

  • Mock audit to verify your current QMS against MDSAP requirements
  • Planning and implementation of needed actions in order to get prepared for a MDSAP audit