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Hackathons are a fantastic environment for networking between academia and industry, and a real opportunity for students and young professionals to showcase their skills. On the last weekend of September 2018, the Victoria Health Hackathon was hosted by the University of Victoria’s Centre for Biomedical Research in downtown Victoria. The event brought together esteemed professionals […]

It behooves designers to look at the assembly processes early, with a focus on how we can stop critical faults or those that are likely to happen. Process Failure Modes and Effects Analysis (PFMEA) is a tool to assess potential process failure points during assembly and how the failures could be felt or observed by […]

Medical devices such as glucose meters, stents or dialysis equipment (to name a few) require intimate contact with biological material. They must either interact with bodily fluids, or function within a biological environment. This blog provides 5 of the most common simulated biological fluid recipes to aide in medical device development.

With an enforcement date of May 25, 2018, the European Union (EU) General Data Protection Regulation (GDPR) is about to impact medical device manufacturers. Though similar to the U.S. Health Insurance Portability and Accountability Act (HIPAA), the new GDPR requirements will influence medical device data services by enhancing privacy and security for EU citizens.

The ability to measure the changes in cells’ mechanical properties can reveal crucial insight into the effects of environmental and pathological stresses. Such properties can have far reaching applications, from its use as a diagnostic tool to stem cell research. In this blog I showcase the technique of Micropipette Aspiration, an inexpensive way to measure […]

Blockchain technology introduces new secured measures for keeping authentic and anonymously real time personal data in decentralized manner. It can be expected that upon maturity the blockchain technology behind Bitcoin will gain the required trust and be used extensively by partners of the highly regulated healthcare ecosystems: patients, regulators, clinics, pharmacies, insurers, laboratories, technology developers […]

As a medical product moves through development to production stage, establishing  supply chain controls to ensure reliable suppliers is critical to satisfy regulatory requirements for your device. ISO 13485:2016 has specific language around supplier controls that needs to be addressed in your QMS. It includes the additional requirements of supplier performance evaluation and controls appropriate […]