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Process validation for Medtech starters
Medical Device starters, do you have more questions than answers on Quality Assurance topics, read my blogs and see if this helps out a little. Reading might be boring (I already start yawning), but it is vital for your company’s success.
Read onProcess validation for Medical 3d-printing is a challenge
Process validation is a challenge for all engineers and all processes, but for 3d printing engineers, the challenge is even bigger.
Read onHow to start Biocompatability Testing
Biocompatibility testing checks if your medical device is compatible with living tissue and systems. For medical devices, the medical device OEM should do these testing according to ISO10993. The norm has 20 parts and can be pretty confusing.
Read onRisk Management Process
With the newest versions of the ISO 13485, the quality management standard for the medical device industry, risk management is increasingly important. Breaking news? No, not really, but still many companies struggle with a good risk management process, and not only the starters.
Read onDesign and Development
Are you a student or researcher making an invention into a medical device? Then read this article about the design and development process, and contact us for more guidance. We can support you with the Design and Development (D&D) process.
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