Regulatory

We are accredited with ISO 9001 quality system and operate in compliance with ISO 13485. We apply rigorous GMP methods for each of our processes.

Our methods are based on concepts of creation and maintenance of historical files that document the phase of progress of the project and changes in post-production.

Progel Engineering has relations with several contract manufacturers. We have defined detailed supply specifications with these manufacturers and we can evaluate which contract suppliers can meet the regulatory aspects required for the production and the further expectations of the customer.

Quality Policy ISO 9001 Certificate