Medical Devices

MEDICAL DEVICES

 Our experience in medical devices covers a broad range of technologies including electro-mechanical, orthopaedic, standalone software and in-vitro diagnostic devices. The services that we offer in this area include:

• Regulatory Clearance

We have advised companies on the appropriate strategy for the CE Marking of their products and assisted them to implement the necessary quality management systems and to prepare the technical file documentation to achieve accreditation. We have also assisted companies to prepare the 510(k) and PMA submissions that are necessary to seek market clearance for such products from the US Food and Drug Administration (FDA).

• Quality Management Systems

We have assisted start up organisations to implement quality management systems that comply with relevant regulatory requirements (European EN ISO 13485 and FDA’s 21 CFR 820) while still being practical and pragmatic to the organisation’s size and needs.

• Risk Management

Our EN ISO 14971 compliant approach to risk management incorporates the principles of risk management into the design control process that is required by both European and US regulation. This approach has been successfully applied to achieve compliance across a broad range of medical device technologies.

• Interim Management

Our consultants have served interim management roles for medical device companies in the areas of regulatory affairs, quality assurance, quality control and validation management.

• Training

We can provide on-site training on any of the areas noted above. Please contact us to discuss your training needs.