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. 

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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.

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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.

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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  

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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