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Process Validation – How to

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.

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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.

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Test Method Validation; easily overlooked

All quality control testing done as part of medical device product release must be validated; Test Method Validation.

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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.

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Comparing Injection Molding and 3D printing: small and large volume production

Where injection molding is already a popular manufacturing process for medical devices, 3D printing is becoming a more and more popular process as well. While both approaches have advantages and disadvantages, businesses must carefully consider several factors to determine which method best suits their needs.

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What CDMOs have to offer

Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in the medical device industry by offering specialised services and expertise that help medical device companies bring their products faster to market.

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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.

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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.

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