While safety in general as well as in the context of medical devices, pharmaceuticals, and combinations thereof, can never be considered in absolute terms, regulatory bodies worldwide require activities to warrant relative safety of such products. Applying the ISO 14971 standard has become a prerequisite in essentially all countries for the successful registration of medical devices or pharmaceuticals including parts that if marketed independently would constitute a medical device.
The ISO 14971 focusses on both the safe and effective use of the product including aspects of usability. It defines the responsibility of the manufacturer to extent throughout the whole lifecycle of a product from the first idea until the expiry of the last batch marketed. In the same way the understanding of “harm” is as broad as including not only the various aspects of health of persons (e.g. physical, mental) but also any harm to the environment and property.
Backed by many years of experience in Risk Management of Medical Devices and Combination Products anteris medical has successfully supported its customers conducting Risk Management throughout the entire product lifecycle. Anteris’ continuous involvement in regulatory activities allows to apply regulatory bodies’ current positions regarding Risk Management to ongoing projects.
Anteris Medical provides standard risk scenarios including harms, hazards, and hazardous situations for commonly used device constituent parts of combination products which proved to be excellent starting points speeding up establishing risk management files tremendously.
- ISO 14971
- Risk Analysis
- Risk Control
- Mitigation Measures
- Risk Management must be realized as an integral part of design and development as well as of the post-launch phase.
- Awareness that Risk Management in the context of Combination Products means separate Risk Management files for the pharmaceutical and the device constituent part.
- Understand that Risk Management for the device constituent part although being separate from Risk Management for the pharmaceutical means managing risk on the combination product level.
- Relies on input from a multidisciplinary team and affects many instances during the design and development of a medical device or Combination Product, resp.
- anteris medical supports its customers in establishing and maintaining the Risk Management file during the entire lifecycle of a product.
- anteris medical provides its experience to factor in Risk Management and resultant activities into project planning and specifically planning for verification/ validation activities early on thus saving time and cost.
- With TachysCP anteris medical offers an easy-to-use software tool to effectively perform Risk Management in the context of the requirements specific for the product under development.