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 Risk Management Series Introduction – Updated 5/22/2020

MEDIcept is presenting this paper as an introduction to an ongoing series of articles focused on the conduct of risk management in the medical device industry.

 Risk Management Series – Part 1: Prioritizing Risk Management Activities

This article presents an approach that device companies have successfully implemented to focus their risk management activities and help to ensure the safety and efficacy of their products.

 Risk Management Series – Part 2: Using Fault Trees to Focus and Simplify Risk Analysis

This article focuses on the use of Fault Tree Analysis to ensure that you take a comprehensive view of hazards/failures before jumping into completing an FMEA.

 Risk Management Series – Part 3: Transferring Risks from Fault Trees to FMEAs

This article describes an approach for transferring risk information from a completed FTA to an FMEA so that you will be able to take advantage of the strengths of both.

 Risk Management Series – Part 4: Key Terms

This article provides a quick review of the more straight-forward terms and spends a bit more time on those that can get confusing.

 Risk Management Series – Part 5: Assigning Harms and Severity

This article provides a quick review of the assignment of Harms and Severities to a particular hazardous situation.

 Risk Management Series – Part 6: Estimating Probability of Occurrence

This article addresses the other major element of risk, the Probability of Occurrence of Harm.

 The Importance of Properly Validating Electronic PLM Systems

The purpose of a product lifecycle management (PLM) system is to manage the entire lifecycle of a product from inception, through engineering design and manufacture, to service and disposal of manufactured products.

Clinical Evaluation Reports – Tying it All Together (Article 1 of 3)

Our team at MEDIcept has worked with a variety of manufacturers to develop Clinical Evaluation Reports for a wide range of devices and device classifications; with these articles, we will provide an overview of the steps for completing a CER and describe the benefits of bringing clinical and safety data, risk analyses, and product literature (e.g. labeling and manuals) together in one place to provide an objective, transparent evaluation of device safety and performance.

As you work to update existing clinical evaluation reports, and create reports for devices that were previously exempted from the requirement, it’s important not to view these reports simply as a regulatory requirement – a report to be created, approved, filed and forgotten. The guidance is structured to help manufacturers bring important safety and performance together – providing a comprehensive evaluation of you devices, and confirming the alignment of key quality system elements. Maintaining these reports throughout the product lifecycle will support the continual improvement of your devices.

Clinical Evaluation Reports – Tying it All Together (Article 2 of 3)

Our team at MEDIcept has worked with a variety of manufacturers to develop Clinical Evaluation Reports (CERs) for a wide range of devices and device classifications; with these articles, we will provide an overview of the steps for completing a CER and describe the benefits of bringing clinical and safety data, risk analyses, and product literature (e.g. labeling and manuals) together in one place to provide an objective, transparent evaluation of device safety and performance. The last article gave a quick overview of CERs and the need for an internal Standard Operating Procedure. This article will discuss the elements of the CER.

Clinical Evaluation Reports – Tying it All Together (Article 3 of 3)

Our team at MEDIcept has worked with a variety of manufacturers to develop Clinical Evaluation Reports (CERs) for a wide range of devices and device classifications; with these articles, we will provide an overview of the steps for completing a CER and describe the benefits of bringing clinical and safety data, risk analyses, and product literature (e.g. labeling and manuals) together in one place to provide an objective, transparent evaluation of device safety and performance. The last two articles gave a quick overview of CERs, the need for an internal Standard Operating Procedure, and the basic elements of the CER. This article will discuss the final CER report.