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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 on
Challenges of process validation for Medical 3d-printing
Process validation is a challenge for all engineers and all processes, but for 3d printing engineers, the challenge is even bigger.Read on
How to start Biocompatibility 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. In this article, we try to give you a good overview.Read on
Risk Management Process
Risk management is increasingly important with the newest versions of ISO 13485, the quality management standard for the medical device industry. Breaking news? No, not really, but still, many companies struggle with a good risk management process, not only the starters. This article explains the process.Read on
Design 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.Read on