qmsWrapper Blog - Take Back Compliance - The Art of Managing Through Quality

This story starts with a medical device startup, who designs and develops a medical device for the early detection of heart disease at the clinical level.

Work smarter, faster with fewer errors

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.

It takes the same amount of time and effort to create a good quality manual as it does a bad one. Oftentimes, far less...

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.

Nobody wants to hire a person that is unable to do a job to a satisfactory standard. This is especially true when it comes to QMS related functions and activities.

It takes the same amount of time and effort to create a good quality manual as it does a bad one.

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.

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.

To pass a certification body audit, a Quality Management System must be an auditable entity with a neat Quality Manual.

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.

A quick reality check of ISO 13485:2016, reveals that it actually looks more, smells more and sounds more, like FDA’s QSR.

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.

This is a real and topical question. At every MedDev or MedTec oriented exhibition this is the off-stage topic, actually more like main grippe session.

The following infographic will help you recognize the primary causes and warning signs for potential data loss and the top tips for prevention.

Documenting improvements are more important that the ideas itself because an idea that is not documented, does not exist.

Typically, small businesses don’t invest in a data backup and recovery plan in place, because they’re unclear about the true value of such solutions.

Ignoring preventive actions might sound like saving money at first, but not investing resources into improving processes will cost more on a long term.

Your risk controls will have a direct impact on your design outputs. An inappropriate risk management strategy will lead to incorrect hazard evaluation.

Risk management is one of the key factors in quality management. Effectively managed risks help companies achieve their goals.

Company policies should include and cover managing, identifying and updating all the documents that contain references to obsolete versions or documents.

If the company is not aware of its context, then that could lead to some real pitfalls since that means there is no real picture.