Risk Management & Regulatory Affairs

Regulations standardise the rules for manufacturers and is the main way to reassure healthcare providers and patients that the devices they are using are trustworthy and will not endanger their safety.

Naturally, certification processes are complex and demanding. We apply our experience with safety-critical applications to help our clients meet industry requirements in a cost-efficient way.

Quality and risk management

A Risk Management Process (following ISO 14971) should be part of any manufacturer’s approach. It will help to identify and analyse project risks, define strategies to mitigate threats, and outline the steps needing to be taken to correct, minimise or avoid their impact.

Managing the different risks right from the start enables a smoother and faster certification process. Critical has considerable experience in supporting clients with the production of all software artefacts and proper documentation for certification, such as:

  • Requirements, Design, Code, Test Specifications, and Reports
  • Product Assurance Files
  • Configuration Management Files
  • Certification Files

Regulatory affairs and consulting

For medical devices to enter the market, they need to receive the necessary regulatory approvals. We support our clients in ensuring their compliance with the relevant standards, such as ISO 13485, IEC 60601 series, ISO 14971, IEC 62304 and 21 CFR Subchapter H, among others.


Critical’s training courses are delivered with the professional background of the delegates in mind. The training courses provide attendees clarification on regulatory requirements and scope, presenting a detailed examination of how they can be implemented by manufacturers looking to efficiently deliver safe, effective and secure medical devices which conform to industry best practices.

Want to know more about our work?

Browse our materials to discover more about what we do for our clients and some of the projects we’ve worked on.

We’ll be glad to help you on any subject we can.

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