GEMARMED helps medical device and pharmaceutical companies across the world to develop medical devices faster, also in close liaison with external specialists having expertise for complex medical technology developments.
Our services are flexible and designed to make life easier for you and your team. If you are looking for more resource or expertise, to quickly pick up a project, solve challenging technical and Regulatory problems or to create a completely new device – then we can help you.
Development risk management and Regulatory strategy
We help speed up your projects and reduce risk, whilst remaining fully compliant with US, EU and UK regulatory requirements.
Our services include risk management to ISO 14971 through using FMEA’s, Fault Tree Analysis etc., and can provide the support required to ensure full project compliance with regulatory requirements.
Development of R&D processes
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.
How can we help?
GemarMed’s regulatory, quality assurance and Design Control expertise and experience allow us to offer our services for DHF filing. Given the necessary authority, accessibility, and other required resources, companies may capitalize on our long-standing and proven track record in successfully designing, applied to the various steps of V&V of medical devices development.