Articles by Mark Durivage

11. FDA Seeks Public Comment On Draft Guidance On Remanufacturing Medical Devices 7/26/2021

    On June 24, 2021, the FDA released a draft guidance, Remanufacturing of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff, for public comment in the Federal Register to help clarify whether repair, servicing, and reprocessing activities performed on devices are likely considered remanufacturing.

12. FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products 7/14/2021

    At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.

13. The Role Of The Contract Manufacturer Under The EU MDR & IVDR 5/31/2021

    As of May 26, 2021, medical device companies must now comply with the EU's Medical Device Regulation (MDR) requirements, and the In Vitro Diagnostics Regulation (IVDR) requirements are effective in May 2022. This article examines the role of the contract manufacturer under these regulations.

14. Establishing An Effective Calibration Program 3/15/2021

    Calibration is the comparison of inspection, measuring, and test equipment against a traceable reference device to determine if accuracy and precision limits are met. It is one of the fundamental, yet often neglected requirements for GMP. Several international standards, regulations, and guidances provide requirements for an effective calibration program.

15. 7 Rules For Properly Interpreting Control Charts 2/15/2021

    It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements. 

16. With Release Of New Guidance Document, FDA Launches Safer Technologies Program for Medical Devices 1/25/2021

    The FDA’s Center for Devices and Radiological Health (CDRH) released the Safer Technologies Program for Medical Devices (STeP) Guidance for Industry and Food and Drug Administration Staff on January 6, 2021, with plans to begin accepting applications for STeP beginning March 8, 2021. Is this a good fit for your medical device or device-led combination product?

17. 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.

18. 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.
    
     

19. ISO's Updated 22442 Animal Tissue Standards — What Changed? 9/29/2020

    This article provides a high-level summary of the updates to ISO 22442-1:2020 ( Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management) and ISO 22442-2:2020 (Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling).

20. Making FMEA More Robust With HACCP 8/27/2020

    Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.