Medical device consultation
- ISO 10993 and 18562 standard clause by clause gap assessment.
- Material Evaluation Summary report preparation
- High Risk material (RohS, RSL, SVHC, CMR ED, Nanomaterial, Substance of animal, plant origin,
- phthalates, PBT etc.) evaluation and justification writing for the in-process or contact material involved in
- the manufacturing of medical devices.
- Scientific literature review as per ISO 10993-1 Annex C
- MSDS (Material Safety Data Sheet), TDS (Technical Data Sheet) preparation
- Interpretation and report writing of the chemical characterization HPLC, MS, FTIR, GCMS, ICPMS, etc.
- Biocompatibility End point selection (on request)
- Biocompatibility Gap Assessment (on request)
- BEP (Biological Evaluation Plan) and BER (Biological Evaluation Report) preparation. (on request)
- Toxicological Risk Assessment (on request)
How professional is our staff
Curiosity, inventiveness, and a passion for excellence. These are qualities that drive our people to discover what’s possible as they work to deliver the best.
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We provide thorough consulting services in pharmaceutical product supply, putting you in touch with partners to optimize your benefits. Our dedication is to promote constructive change for a better future.
Services
Extractable and leachable
Solid state Research
Nanomedicines Analytical development
CMC documentation and innovations
Synthetic chemistry
Analytical R & D Services
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+31 633409949
snayak@versaklabs.com
