Regulatory Affairs

Maximizing Information to Minimize Regulatory Risk

No industry is more regulated than Life Sciences as it deals directly with precious human lives.  To be in business, medical device and other life sciences companies around the world must comply with regulations set by their governments: the Food and Drug Administration (FDA) in the United States, the Medicines Agency in Europe, the Ministry of Health in Japan, the Ministry of Health, Labour and Welfare (MHLW) in Canada and so on.  Progressive medical device companies are proactively engaged in self-monitoring of its product quality issues.  Given expanded government authorities and increasing potential lawsuits, the costs and risks associated with inconsistent product quality and non-compliance are simply too great.

Dassault Systèmes' (DS) solution for Life Sciences organizations offers the ability to create and manage electronic submissions (e-Submissions) to the above regulatory agencies when requesting for new product approval.  In addition, electronic approval matrices are provided to capture electronic signatures in response to the FDA's CFR Part 11 regulatory procedure.  Many life sciences organizations have started to use electronic submissions (e-Submissions) and signatures so that regulatory agencies can track and speed up new product approval process. This can be part of quality management initiatives that can provide support to expedite the documentation and submission process.

ENOVIA provides an end-to-end solution that manages all of the elements of a life sciences company's quality system regulatory compliance and ISO-regulated design control.   This flexible solution manages all quality issues including product complaints, NCRs, Audits and CAPAs through a single, global, on-line system to avoid compliance risks, improve productivity and drive innovation in product development.  These quality processes are easily integrated with all aspects of the product lifecycle, giving them direct reach into the processes they seek to improve, which include inspections, reporting, purchasing, verification, validation, submissions and misbranding.

DS Solution for Medical Device Regulatory Affairs includes:

  • Regulatory submission assembly
  • Electronic & paper submission
  • Regulatory relationship management
  • Clinical trial design and planning
  • Clinical trial execution

Regulatory authorities have no reason to question anything since mistakes and misunderstandings can easily be avoided. As a matter of fact, the FDA praised us by saying that we have excellent control over our information.

Bo Nilsson Manager R&D, Elekta