ISO 13485:2016 and risk management (ISO 14971) set-up for medical device manufacturers and distributors.
Quote by scope
In the medical device sector, quality management is intertwined with regulatory requirements. Our consulting covers design and development controls, risk management, verification and validation, traceability, and complaint and vigilance processes.
Scope
- Mapping of regulatory requirements and system design
- Design file, design inputs and outputs, verification and validation records
- Risk management file according to ISO 14971
- Sterilisation, packaging and clean-room control documents
- Supplier and subcontractor control
- Complaint, corrective action and vigilance procedures
Who is it suitable for?
It suits manufacturers of single-use surgical products, dental supplies, orthopaedic products, in-vitro diagnostics and medical software. A consultant experienced in the medical field is assigned; projects can last 20 to 30 weeks and you are directed to a certification body suitable for your product class.
Process and outputs
At the end of the project the quality manual, design file templates, risk management file, verification and validation protocols and traceability records are handed over. An annual review session for updates to regulatory requirements is also recommended.
Scope of service
- ISO 14971 risk file
- Design control records
- Vigilance procedures
- Consultant experienced in medical
ISO 13485 Medical Device Quality System Consulting — get a quote
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