We work according to our ISO 13485 process or work flexibly within your own systems. Numerous global medical devices and pharma companies trust us to work on their devices, drug-device combination products, both parenteral, intramuscular or inhalation. Client’s value our diverse experience to bring fresh thinking, that we are adaptable, easy to work with and have a friendly team.
During device development, full Design Controls are applied within our formal device development process and Verification&Validation (V&V). This ensures MDR and FDA Compliance and projects properly managed, since at GEMARMED we understand the burden of compliance and that it can bog a project down.
We ensure our process and outputs for regulatory submission are highly efficient by using our traceability software.
If you are encountering difficulties, need expertise, resource or have a problem to solve then please contact us or give us a call, we will always try to help.