Regulation / Standard Compliance

Tonson labs have developed, supported and released dozens of products according to the strictest standards and regulatory requirements, and that passed regulation checks on the first time. Our whole approach is regulations targeted, and we are up to date on regulations, standards and perform our initial planning, engineering and design based on this knowledge, as well as other customer specific requirements. This approach controls the development process as well as the detailed documentation and the final product quality.

At Tonson Labs we support full DHF and DMR files, which means that the whole development process is recorded into the documentation, and this enables us to pass 60601, CE, FDA in a very short time. Quality is one of our core values and we are ISO9001 and ISO13485 compliant.

As experts in the medical device market we provide you with these advantages:

  • Thorough Knowledge of the regulatory requirements and local standards
  • Architectural adaptation to the required regulation or standard for a product developed from scratch
  • Efficient design changes needed to a developed product with minimal impact to schedule and budget
  • Guidance to passing regulatory checks, and methods for keeping records and documenting processes
  • Guidance to passing regulatory checks, and methods for keeping records and documenting processes

The medical devices market is constantly changing and expanding, and keeping in line with regulations is a must. In order for your product to be on the market on time – considering the regulatory aspect from day one is imperative.