Quality Consultancy (Medical Device)
ISO13485 Medical Device Quality Management System –
All medical device manufacturers who are marketing and selling their products within the EU, need to maintain the controls for the product lifecycle within a documented quality management system. Class IIa, IIb and III devices produced under a full quality assurance system must be in accordance to ISO 13485.
We offer support in:
– Gap Analysis
– Quality System Development and Improvement
– Internal and Supplier Auditing
– FDA and MDSAP inspection readiness and support