The regulatory world can be difficult to navigate with convoluted regulations. The sheer volume of requirements and, on occasion, their lack of clear instruction, may make compliance appear a daunting task. However, with the right knowledge and experience, the universal nature of regulations creates opportunities to streamline the approval process,

A well-devised regulatory strategy leveraging the nuances of each jurisdiction’s regulatory requirements can save significant costs and time to market, but this requires intimate knowledge of the intricacies of these requirements. Vestech Medical has first-hand experience in composing regulatory strategies for a wide range of jurisdictions, including:

  • USA (FDA with 510k, De-Novo or PMA market pathways),
  • European Union (CE marking and MDR 2017/745)
  • Canada (Health Canada and MDSAP)
  • UK (MHRA regulations), and
  • Australia (TGA, Therapeutic Goods (Medical Devices) Regulations)

Vestech Medical also provides support for regulatory submissions, be it with 510k submissions to the FDA, compiling the design dossier for EU submission or registering the device with the TGA . Vestech Medical can also perform a gap analysis of your technical document against applicable regulations and standards.

Vestech Medical is well experienced in preparing documentation for regulatory submission and will work diligently with you to achieve regulatory approval in a timely fashion. Examples include a 510k for an electromechanical device with software (phone App), CE marking of a sterile spinal screw and multiple TGA inclusions of medical devices.

One particular client engaged us to do a gap analysis of their technical documentation against TGA regulations. The review found some requirements were lacking, including labelling. With our feedback and support the client was able to update the technical documentation and was successful in obtaining regulatory approval in Australia.

For more information on how else Vestech Medical can support you,

see the links below.