Regulatory Articles

  1. Common Reasons For FDA Form 483 Observations And Warning Letters In Medical Device Environments 8/31/2021

    By understanding the FDA’s updated approach to medical device regulation and the information provided in the inspection observations document, medical device companies can more easily identify and mitigate compliance issues.

  2. ISO 13485 - Change? Do I Have To?? 8/31/2021

    Accordingly, many companies have a conundrum if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system. The array of opportunity may not be as broad in terms of rationalizing how to do business as an outlier.

  3. Most Common Reasons For FDA Form 483 Observations And Warning Letters In Medical Device Environments 8/26/2021

    When the FDA conducts regulatory inspections, issues that are considered objectionable conditions or compliance violations by FDA inspectors are itemized in a Form 483 or a warning letter. In this article, we help you understand the FDA’s updated approach to medical device regulation and provide information about inspection observations so you identify and mitigate compliance issues more easily.

  4. EU MDR: How To Prepare for The Upcoming Changes In Regulation 8/24/2021

    Recognizing the need to enforce heightened safety measures and risk management processes, the European Parliament and the Council of the European Union developed the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in 2017. 

  5. The New Digital Pathway For Regulatory 8/23/2021

    As medical devices become more complex – mixing both device and drug delivery and/or integrating software, applications or connected sensors – the regulatory environment is becoming more challenging. Companies must strategically invest in a strong interoperable digital infrastructure, and harness data to expand their business models and position themselves to compete in a transformed environment.

  6. Finding The Ideal Balance — Where Risk And Cost Of Quality Meet 10/6/2020

    It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.

  7. Experimental Design And Positive Controls For Package Integrity 4/9/2020

    Given that the experimental design has only two conditions, leaking and non-leaking, this variable is extremely important to understand. Proper use of positive controls and knowledge of how alternative approaches are applied to challenge a test method support the validity and reliability of the method.

  8. A Critical Analysis of FDA Guidance for User Percentile Device Design Criteria Versus Currently Available Human Factors Engineering Data Sources and Industry Best Practices 7/9/2019

    It has been reported that 83,000 deaths and 1.7 million injuries have been linked to medical devices adverse events over the past decade. There is indication that some aspects of both medical device human factors engineering (HFE) design and Food and Drug Administration (FDA) HFE validation criteria may not provide proper methodologies for selecting and testing patient populations, possibly leading to medical devices that pass FDA HFE validation yet still exhibit significant use errors when utilized in the real world. This paper explores the possible sources of HFE performance problems with medical devices and links potential problems to HFE validation methodologies within the FDA HFE guidance framework.

  9. Preparing For MDR? Start With A Gap Analysis 5/14/2019

    With the EU MDR going into effect in about a year, medical device manufacturers are gearing up to prepare product lines for the massive regulatory changes. The planning and pre-clinical testing necessary for MDR compliance can be an exhaustive, multi-faceted venture. 

  10. Single-Touch Labeling: The Answer To EU MDR? 4/29/2019

    Warren Stacey, PRISYM ID, examines a single-source approach that could eradicate data duplication, inconsistencies, and costly human error.