“While technology is important, it’s what we do with it that truly matters.”
Muhammad Yunus, Nobel Peace Prize, Chancellor of Glasgow Caledonian University
Medical Device Directive
3 Medical Devices Directives
- Active Implantable Medical Devices (90/385/EEC)
- Medical Devices (93/42/EEC) amended by 2007/47/EC
Consists of
- 23 Articles
- 12 Annexes
- 18 Classification Rules
Scope
- Specifies essential requirements
- Introduces controls covering the safety, performance, specification, design
- Manufacture and packaging of devices
Quality Management System for Medical Devices ISO 13485
Implementation of this standard will ensure that devices comply with the essential requirements of the medical device directive
- Documentation and Control of documents
- Management Responsibility
- Resource Management
- Product Realisation
- Measurement Analysis and Improvement
- Risk Management
- Traceability
- Vigilance
Kinesys Services
- Regulatory Affairs
- Technical File
- Design Dossier
- Design History
- Quality Management Systems
- Implementation
- Internal Audit Program
- Out Sources Quality Manager
- Risk Management
- Clinical Evaluation
Kinesys Experience
- Experience of managing a range of medical device developments from initial concept through to regulatory approval and launch onto the market
- Extensive quality management experience in the medical devices field and audit for BS EN ISO 13485
- Experience in medtech and biotech, project management, commercialisation, regulatory pathways, product and manufacturing development