Guest Columns

41. 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.

42. Tips For Building A Voluntary QA Culture In A 2021 COVID World 12/21/2020

    As we say goodbye to 2020, the end of which couldn’t come soon enough, it is fitting to look at how to build a voluntary quality culture in our “new normal” work environment.

43. 3 Creative Ways To Develop A Better UI For Your Medical Device 12/17/2020

    If you're an engineer, you were told in school that either you can't or don't need to participate in artistic activities — but that has unfairly pigeonholed you. Rethink what you've been taught about creative problem-solving! Tom KraMer of Kablooe Design discusses his three tips that result in a better user interface for your device.

44. 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.

45. 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.

46. Fluid Management Equipment Market Poised For Growth In Europe 12/7/2020

    In the gynecology market, as the use of hysteroscopes and other less invasive methods increases, more procedures will require the use of fluid management equipment. Notably, there has been significant growth in the sales of both capital equipment and tubing for fluid management during hysteroscopic procedures. This article discusses the current and future fluid management market in Europe.

47. Will Transcatheter Valves Continue Cannibalizing Surgical Aortic Valve Replacements? 11/30/2020

    In 2019, the transcatheter aortic valve implantation (TAVI) device market garnered nearly 7 times that of the surgical aortic valve market. TAVI procedures are expected to account for an even larger share of aortic heart valve replacement procedures in Europe in 2021.

48. 4 Emerging Approaches to Medtech Contracting Agreements 11/25/2020

    In recent years, a range of factors, including increasing budget pressures, requirements for real-world data, the availability of more innovative medical devices and technologies, and the shift toward value-based care are driving the development of new pricing and reimbursement models in the medical device sector. What are the four medtech contracting agreements that have emerged?

49. 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.

50. 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.