CE Marking / Testing / Certification
CE Marking / Testing / Certification
We can help with all Healthcare CE Marking, Testing & Certification issues, including audits, technical documentation and drafting of CE declarations of conformity.
- Certification / Regulatory Pathway Services
- On site consultation, Mock ISO 13485:2016 system and compliance audits
- Technical File Construction - Technical documentation
- Product Design reviews and Clinical evaluations reviews
- Standards Investigation and Change Control Management
- Risk assessment & development of strategies for risk management and control
- CE Technical files reviews
- Quality Systems - ISO 9001: 2015/ISO13485: 2016
- Training - on-site
- Essential Requirement Reviews
- Audit preparation & Registration
- Access to and approval with European Notified competent bodies
- Intended use /Classification of devices
- Label and IFU Drafting and reviews
- Drafting of CE declaration of conformity
