Our Expertise

    We offer to you in depth knowledge combined with practical experience gained in medical device companies in the following key areas:

    1. Quality systems - implementation, preparing for ISO certification or FDA inspection and auditing in line with international regulations and standards, e.g. :

    • 93/42/EEC:
    		 Medical Device Directive (MDD)
    • 90/385/EEC:
    		 Active Implantable Medical Device Directive (AIMD)
    • 2007/47/EC:
    		 Amendment to MDD and AIMD (among others)
    • EU MDR
    		 Regulation of the European Parliament and of the Council on medical devices
    • ISO 13485:2016 / EN ISO13485:2016:
    		Quality management system requirements medical devices
    • ISO 9001:2015
    		Quality management system requirements
    • ISO14971:2007 / EN ISO 14971:2012
    		Application of risk management to medical devices
    • 21CFR820:
    		 cGMP / Quality System Regulations (US FDA)
    • 21CFR11:
    		 Electronic records and signatures (US FDA)
    • Etc.

    2. Obtaining regulatory approval for specific medical devices to international markets, e.g.:

    • CE marking (EU)
    • PMA, 510K, de novo (US)

    3. Software validation and process validation support, covering e.g.;

    • validation of medical device software, e.g. in line with IEC 62304 and FDA regulations and guidance as applicable
    • validation of software used in production, service or (other) parts of the quality system in line with notified body expectations and applicable FDA regulations and guidance including 21CFR11 regarding electronic records & signatures as applicable
    • validation of manufacturing processes in line with notified body expectations and applicable FDA regulations and guidance

    4. Organizational and business process improvement e.g. via:

    • 6 sigma approach
    • Baldrige and EFQM models
    • Strategy development and deployment
    • Balanced score cards
    • Problem analysis and problem solving techniques