Guest Columns

11. ISO 10993: Considerations For Drug Delivery Devices 12/4/2019

    A host of factors come in to play when evaluating biocompatibility, including how the medical device is sterilized, how the device is used, what body parts it makes contact with, and selecting testing approaches.

12. What Does IMDRF’s New Cybersecurity Guidance Mean For You? 12/2/2019

    Principles and Practices for Medical Device Cybersecurity is intended to help facilitate international regulatory convergence on medical device cybersecurity by explaining fundamental concepts, best practices, and recommendations for all stakeholders.

13. Documentation Priority For Early Stage Medtechs — Part 1: User Specification 11/25/2019

    This article lays out considerations and a process for developing user specifications when developing a new medical device. It is the first in a series that examines – and prioritizes -- necessary documentation when creating early an proof-of-concept prototype.

14. People: The Most Persistent Risk To Data Integrity 11/15/2019

    HR changes continually impact overall data integrity—from a single new hire to a corporate-level change with a merger or acquisition. It's a commonly overlooked weak link in the data integrity chain.

15. FDA's Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program Explained 11/13/2019

    The ASCA Pilot is intended to provide increased confidence in testing results from ASCA-accredited testing laboratories, as well as decrease the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories.

16. SOP Remediation: When Reinventing The Wheel Is The Best Approach 11/12/2019

    When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when you factor in time, human resources, and long-term outcomes.

17. Closing Quality Gaps: 7 Steps To Properly Resource A Remediation Project 11/4/2019

    Teams often rely on ad hoc resource allocation and a naively hopeful attitude about the qualifications and capabilities of project team members. These tips can help you avoid such mistakes and improve the chances of your project's success.

18. China’s Medtech Goals 10/30/2019

    This article presents challenges facing the Chinese medtech space and details how the country’s government currently manages these issues, as well as how it plans to do so going forward.

19. FDA Updates Several 510(k) Guidance Documents 10/21/2019

    The FDA recently issued four final guidance documents governing 510(k) regulatory submissions, covering the Special, Abbreviated and Traditional 510(k) pathways, as well as the Refuse to Accept Policy for 510(k)s.

20. Intro To Prefilled Syringe Selection: Staked-In Needles 10/15/2019

    This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes. Part 2 examines the various aspects of prefilled syringes with staked-in needles and their impacts.