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FastFiles
Our new FastFile service ensures quick turnaround of a complete
technical file conforming to the applicable directive requirements. Our service
includes:
- Review of supporting documentation and preparation of
summaries for inclusion in file.
- Existing product labelling review and editing for compliance
with European regulations in the English language only.
- Technical file, essential requirements checklist, risk
analysis, and declaration of conformity preparation
- Working with the customer to coordinate the completion of
any of the documents needed below.
All services will be delivered within 3 weeks from issuance of P.O.
or credit card charge (Mastercard, Visa, and American Express), and submitting all
of the following documents:
- Identity and address of EU Authorized
Representative (CRO Group can act as this,
click here for info)
- List of applicable part/catalog numbers for the products and accessories if any
- List of all hazards and failure modes
- FDA 510k clearance letter(s) if applicable
- Quantity of MDR and non-MDR complaints per units sold for the past 365 days.
- Details on materials of composition and manufacturing methods of product
- Product and any accessory design documentation (drawings and or specification)
- Test or validation records of European/International standards conformity for
clinical utility (can either be clinical trial report, article in a journal, or a
manuscript), biocompatibility, performance tests (tensile, adhesion, etc.), software, sterility, packaging integrity (if supplied sterile)
- Example of existing product, product labelling including labels, package
inserts/use instructions, contraindications, etc, and product packaging.
To obtain a quote, place an order, or request further information, click here. |