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Regulatory compliance

Regulatory assesments

Why we do this

This involves analysing the relevant regulations and standards that apply to either a product or service. We work with clients to identify the appropriate regulatory requirements and assess the level of regulatory risk associated with the product or service.

Regulatory planning

Why we do this:

Once the regulatory requirements have been identified, we can help clients to develop a regulatory plan. This plan will outline the regulatory pathway for the product or service, including the types of regulatory submissions that will be required and the timelines for each submission.

Keeping up to date

Why we do this

As regulations change and evolve, our team will update the regulatory strategy to ensure that the products remain compliant. This may involve updating the regulatory plan, preparing new submissions, or making changes to the product to ensure ongoing compliance.

Up next…

Regulatory strategy report

We help our clients understand and comply with laws, regulations, standards, and other requirements that apply to them.

As an accredited ISO 13485 company, we assess the safety and performance of medical devices and applications, as well as increase the likelihood of regulatory approval and market access. By following the standard, we can demonstrate our commitment to quality, patient safety, and regulatory compliance.