Showing posts tagged with: risk management

It’s always good to think a step ahead, and exactly that is what our Cup of Joe wants to tell you about. qmsWrapper is constantly working on improvements and keeps up with the changes in the market that considers Medical Device startups and manufacturers. The new MDR is set to become applicable in May 2020. One of...

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 certification, ISO14971 is essential. And in May of 2020, the...

27th November 2019 Toronto, CA - QmsWrapper, a world-famous QMS System that helps Meddev startups and small businesses achieve and manage ISO 13485:2016 and 21 CFR 820, announces that the future is now available with the latest release where vision meets functionality.  Vs6.0 will radically change the way you look at QMS. It moves away from being...

“Efficiency without Effectiveness misses the Purpose Effectiveness without Efficiency misses all the Profit Effectiveness 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 of corrective and preventive actions (CAPA) is to improve the organization processes...

What is the root cause analysis? Root Cause Analysis is something that we all do when we want to solve a problem for good. But what RCA actually means? It means to find what caused the problem, to find out not only what went wrong in the beginning, but how, when and why as well. Basically, RCA is...

CAPA – Corrective action Preventive action The purpose of corrective and preventive action is to collect and inspect information, identify and examine the product or potential quality problems, then take suitable and effective corrective/preventive action. It’s a process of improvement taken to eliminate causes of possible malfunction, problems, or other unwanted situations.  It’s also a process that...

Whether you are freshly minted into the QMS position or you are a founder of a Startup or a product manager with a new project…your strategy requires QMS oversight. MS Joe will guide you with handy tips & tricks to streamline your way to compliance.   The Relation Between Risk Assessment and Opportunities to Improve Companies often fail to...

Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project… your strategy requires QMS oversight. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.   Are Corrective Actions More Important Than Preventive Actions? Although CAPA is...

Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project… your strategy requires QMS oversight. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.   Deer, Rabbits and Fast Snails, Risk is About Context Risk management...

In our fast-paced world, the risks we have to take and manage, in order to continue to grow and to develop, evolve quickly. Effectively managed risks help companies achieve their goals. Products that are developed following quality standards, have improved the quality of life for thousands of people. The idea of improving the quality of life...

Whether you are freshly minted into the QMS position or you are a founder of a Startup or a product manager with a new project… your strategy requires QMS oversight. QMS Joe is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to...

Whether you are freshly minted into the QMS position or you are a founder of a Startup or a product manager with a new project… your strategy requires QMS oversight. QMS Joe is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to...

  ” Risk /rɪsk/, noun the possibility that something unpleasant or unwelcome will happen. Synonyms: chance, uncertainty, unpredictability, instability, riskiness…”   We’re dealing with countless risks in our daily life, like getting cut during apple slicing, or catching a cold if we get wet on a rainy day…or planning a project without a proper risk management plan…  Unknowingly you are doing...