Regulatory & Compliance Perspectives

1. Using Production And Postmarket Data To Validate FMEA Assumptions 1/15/2021

   One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.

2. Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: Risk-Based Trending 1/6/2021

   Risk-based incident trending for postmarket signal detection is quickly becoming an expectation from most regulatory agencies and EU MDR is one of the first regulations to expressly document this requirement. Jayet Moon concludes his four-part article series on risk-based postmarket surveillance in the age of EU MDR by examining the salient features of a sound risk-based trending process and methodology and discussing what to look for in a trend analysis.

3. Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: The Binding Thread Of Risk Management 12/22/2020

   The thread of risk management connects every piece in the quality management system and guides the manufacturer in quality related decision-making throughout the lifecycle of the device. In Part 3 of his article series on risk-based postmarket surveillance (PMS) in the age of EU MDR, Jayet Moon discusses how quality risk management and PMS are natural partners. He also examines the five elements for which the PMS system should be on the lookout.

4. Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: A Systems Approach 12/15/2020

   Jayet Moon continues his four-part series on risk-based postmarket surveillance in the age of the EU Medical Device Regulations (MDR) with Part 2, which delves into the systems approach. Such an approach gives due consideration to process interfaces with other organizational functions and knowledge management. It would not only make compliance to EU MDR easy but also make the organizational processes much more effective and efficient.

5. Risk-Based Postmarket Surveillance In The Age Of EU MDR: Incident Investigation 12/11/2020

   Jayet Moon begins this four-part series on risk-based postmarket surveillance (PMS) in the age of EU MDR by delving into the incident investigation. Such investigations are the basic iota of the PMS system upon which all further analysis, synthesis, and decision-making is based. By looking into the Who? What? When? Where? Why? and How? of serious events related to your device, you'll be able to provide answers to regulatory bodies.

6. Brexit Finalization: How Will Medical Device Compliance Change In Europe In Jan. 2021? 11/23/2020

   The UK's transition period in leaving the European Union ends on December 31, 2020. The Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medical devices marketed in the UK, released new guidelines in September 2020 detailing how devices will be regulated beginning January 1, 2021, with varied compliance dates for different device classes.

7. ISO TR 24971:2020 — Bringing Clarity To Risk Acceptability In ISO 14971 11/19/2020

   With ISO TR 24971:2020, the technical committee responsible for the medical device risk management standard has finally addressed the confusion around the policy for risk acceptability criteria and the difference between that and the criteria themselves.

8. Pandemic Accelerates Expanding Role Of Real-World Evidence In FDA Medical Device Submissions 11/4/2020

   By forcing the FDA to become comfortable with the use of real-world data in order to authorize COVID-19 diagnostic tests, the pandemic may have unintentionally forced the agency to reflect in a more pragmatic way on what characteristics of real-world evidence (RWE) it believes are essential for data integrity and what level of uncertainty it can tolerate in connection with RWE.

9. How To Implement Continuous Process Monitoring Of Validated Processes 10/28/2020

   It is time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements if you do not want to be cited by the FDA.
   
    

10. ISO 14971: Harnessing Preliminary Hazard Analysis (PHA) To Develop Safer Medical Devices 10/19/2020

    Engineers tend to focus on device failures and failure modes, and their causes and effects, in order to make sure the device “works” reliably. But device failures and failure modes don’t necessarily lead to hazardous situations and harms, and harms can occur even when there is no device malfunction. This is where a preliminary hazard analysis (PHA) can help.