Risk Analysis Module becomes a very important update, next to other features: Traceability Matrix, Process Engine, and Jira integration. Changes will make Risk Assessment much easier and clearer. In the medical device world, risk-based design and development is the new norm. For FDA clearance and CE Mark…
Data loss or damage is costly, extremely risky and can affect your brand reputation. Perils might come in many forms, as natural disasters (e.g. hurricanes, floods, fire) or uncontrollable human errors, power surges, technical malfunctions and increasingly malware attacks. You need a backup plan and…
Surprisingly, this is a real and topical question. At every MedDev or MedTech oriented exhibition this is the off-stage topic, actually more like the main grippe session. The 2016 ISO version requires a lot more emphasis on risk management and embedding risk management into the…
Document what you do and do what you document Quality Manual is the foundation and framework from where you build your organization. It is a plan, which sets the direction and navigates the organization within the defined parameters. Like any plan, it is good to…
You, as a medical device manufacturer, are responsible for gathering certain key information about your device for the CE mark. When we say key information, we mean technical documentation. All those documents you have to have it in one place, organized, before providing the final…
In the previous article, we took a closer look at ISO13485:2016 and the pending doomsday scenario. In this article, I’ll take a closer look at the similarities between ISO 13485:2016 and FDA QSRs. Similarities between ISO 13485:2016 and FDA QSR A quick reality check of…
As a medical device manufacturer which wants to place its product on the European market, you must be aware of all requirements to do so. Of course, one of the first things, you need to comply with Europe’s Medical Device Regulation (MDR). There are few…
When I say Validation For Intended Use, most of you picture an extensive documentation required by ISO and FDA.Although Validation for intended use documentation is useful for several reasons (ensure accuracy, reliability, consistent intended performance, the ability to discern invalid or altered records, etc.) people…
The most important part of the manual is the description of the QMS The quality manual provides a wide range of benefits for organizations. Besides, that is easy to follow, it covers almost everything that company and its employees need to know about the ISO…
CE mark? It’s a symbol, it’s a declaration, it’s a proof, it’s validation, it’s European. As a medical device manufacturer, you are aware of the importance of FDA approval, of course, if you are in America. If you are chasing the European market, you know…
