Medical Products
YOUR PARTNER FOR REGULATORY AND QUALITY COMPLIANCE
IN MEDICAL DEVICE INDUSTRY
The key factors leading to inherently safe design planning
Like each product realization process, the heart of an effective design process is planning. It does not matter, if you are after a simple medical device or starting the design of a high-tech complex structure. In each case, if we are talking about a medical device, the key route to safety starts at the planning stage. The design plan shall cover every bit of product life cycle and reference activities like verification, validation, and design transfer which are appropriate at each design stage.
We know how difficult planning all design requirements can be. Especially for start-ups, at the initial design phases, the long requirement list may result in endless discussions and become a real challenge. ON Outsource partnered experts can support you throughout all design stages.
OUR SERVICES
Consultancy
Whether you are a small start-up, requiring an effective regulatory watch or a mature company looking for detailed
Audit
On-site and remote audit services are ideal to have a final review of your technical files or QMS before the certification audit.
In House Training
During Covid 19 we remote in house training courses to improve staff knowledge, competency and regulatory skills.
Design Control
ON Outsource helps you ensure that your medical device complies with the applicable standards and regulatory requirements.
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