Services
From quality system to CE mark, across six areas.
Each area can be taken on its own, or planned together as the full route to CE marking.
ISO 13485 Quality Management System
An ISO 13485:2016 quality management system for medical device manufacturers, importers and distributors. If you already have a system, we review it against the standard and MDR Article 10 and close the gaps.
Scope
- Gap analysis
- Process map and procedures
- Internal audit and management review
- Certification audit preparation
- Closing audit findings (CAPA)
MDR 2017/745 Compliance
A roadmap for moving MDD-certified products to the MDR, or for bringing a new product to its first CE mark. We plan the full path from classification to the notified body application.
Scope
- Device classification and conformity assessment route
- MDD to MDR transition plan
- General safety and performance requirements (Annex I) analysis
- UDI assignment and EUDAMED registration
- Notified body application and review support
Technical Documentation
Technical documentation structured according to MDR Annex II and Annex III. We can build the file from the start, or review your existing file ahead of the notified body assessment.
Scope
- Device description, variants and intended purpose
- GSPR checklist and applied standards
- Design and manufacturing information
- Label and instructions for use review
- Post-market surveillance (PMS) plan and PSUR
Clinical Evaluation
Clinical evaluation according to MDR Article 61 and Annex XIV. We gather clinical data through a systematic literature search and set out equivalence and sufficiency of evidence with clear justification.
Scope
- Clinical evaluation plan (CEP)
- Systematic literature search
- Clinical evaluation report (CER)
- PMCF plan and evaluation report
- Summary of safety and clinical performance (SSCP)
Risk Management
A risk management file compliant with ISO 14971:2019 that can be kept current across the product life cycle. We link risk management to clinical evaluation and PMS outputs.
Scope
- Risk management plan
- Identification of hazards and hazardous situations
- Risk analysis, evaluation and control measures
- Benefit-risk analysis and overall residual risk evaluation
- Monitoring production and post-production information
Training
Hands-on training where your team works on its own products and documents rather than generic slides. Content and duration are set according to participants' roles.
Scope
- MDR 2017/745 fundamentals
- ISO 13485 fundamentals and internal auditor
- ISO 14971 risk management
- Clinical evaluation and PMS
- Technical documentation workshop
Let's talk about your project.
Tell us briefly about your product and where you are in the process; we will work out the right way to proceed together.