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…
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…
Tips and guidelines to create an efficient workforce and keep your business functioning at a high level. (ISO 9001, ISO13485, FDA510K) Nobody wants to hire a person that is unable to do a job to a satisfactory standard. This is especially true when it comes…
It takes the same amount of time and effort to create a good quality manual as it does a bad one. Oftentimes, far less… In this article, we will discuss how to establish, operate and maintain a good one: Quality Manual = The Quality Bible…
Traceability is required by regulations. Traceability Matrix Updated 2019, For FDA, 510(k), DeNovo or PMA, traceability is required as part of your Design History File (DHF). Soup to nuts, they expect you to demonstrate how it is all connected, where and how requirements were met.…
The new version of qmsWrapper is updated in December 2019. We were still shaking from a disastrous ISO audit. Joe, the perennial QMS manager from Jurassic times, just have been fired. Even though he liked pushing the paper-based system, a medical device company has too many…
Audit – a word that inspires anxiety. Even when everything is well planned, and you think you are prepared, anticipation turns to anxiety, anxiety to fear, and fear to panic. There is no hiding anything in a remote closet or under the carpet. “Wherever you’ve…
The power of trade shows is impressive. From showcasing your newest products, to expand your customer base, close sales, keep an eye on your competition, expand your distributor network, meet face to face with your remote customers, expand your industry contacts, recruit new employees, explore…
“Efficiency without Effectiveness misses the PurposeEffectiveness without Efficiency misses all the ProfitEffectiveness with Efficiency brings Performance.”― Martin U. Ugwu Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop between identifying a problem and completing the actions to solve it. Reminder: The main purpose…
Now Medical Device startups and small businesses that use Jira can be connected to qmsWrapper. This integration will help medical device companies reduce their development risks and increase their agile effectiveness, whilst still keeping an eye on quality. “qmsWrapper got its name because it originally…
