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Regulatory support

Regulatory Support

Robust regulatory documentation and responding effectively to an evolving regulatory landscape requires an approach to materials that is rigorous, systematic and informed by depth and breadth of experience. 

We put fundamentals first and offer an approach that is unbiased, efficient and informed with respect to user, quality, and manufacturing constraints; and augment this with services that ensure consistent, logical, comprehensive and easy to understand results. We have completed many remote and on-site regulatory assignments providing a resourceful extension of in-house resources.

Please find our services and range of experience below. We would also be delighted to hear from you if you have any questions or suggestions regarding our services.

Services and key areas of expertise include:

  • MDR Compliance/Gap Analysis 

  • REACH Regulation compliance

  • De-risking raw material supply

  • Expert assessment of products for food/biological contact including residual monomers and additives

  • Addressing and avoiding restricted substance/Substances of Very High Concern (SVHC) issues in components and devices through better material and process decisions

  • Assessment of predicate device materials/Identifying materials that have already been used for a particular device or application

  • Finding FDA approved devices or recall information for particular materials and application

  • Assessment of new and existing materials for biocompatibility or supply issues

  • Rationales for establishing/closing CAPAs

  • Establishing substantial equivalence

  • Rationalising the scope of T0 functional testing relative to existing post-sterilsation, accelerated aging and biocompatibility test data 

Specific projects undertaken to date include:

  • Assessment of toxicological, regulatory or supply risks arising for PVC substitutes in healthcare packaging

  • Evaluation of POK as a substitute for healthcare components affected by supply constraints

  • Rationale for releasing 3 year shelf life polyolefin-based product at T0 based on existing data

  • Justification for removing polytetrafluoroethylene and silicone oil from Positive Expiratory Pressure device without repeating biocompatibility testing

  • Justification for PPE device storage temperature limits

  • Rationalising the scope of functional testing to support transfer of key component manufacture

  • Assessment of regulatory and supply risk for polymers in product materials and opportunities to reduce environmental impact

  • Finding the best ‘Green Deal substitutes’ and how to reduce risk, environmental impact and material costs

  • Justification for removal of post-cure in LSR moulded medical device components

  • Mitigating against supply and regulatory risks by transferring key manufacturing process from external vendor to on-site location  

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