Subscribe to our blog
Blog Filter Menu

Product

Regulation

Topic

Sorry, no listings found for that Search. Try changing your fiter and search again.

  • Medical Device Software: Top Regulatory Submission/File Deficiencies and Requests for Additional Info From Both FDA and Notified Bodies
    Medical Devices | Ivd

    Medical Device Software: Top Regulatory Submission/File Deficiencies and Requests for Additional Info From Both FDA and Notified Bodies

    on 29 November 2022 | By Kevin Go, MBA, RAC, CQA, RQM+ Senior Principal

    Medical devices that fall into the category of software as a medical device (SaMD) are on the rise as technology continues to evolve. Although these products have proven to be highly beneficial to patients and end users, manufacturers must overcome many regulatory challenges.

    Read More
  • How to Submit FDA CDRH Submissions Online
    Fda

    How to Submit FDA CDRH Submissions Online

    on 27 July 2022 | By Kevin Go, MBA, RAC, CQA, RQM+ Senior Principal

    As part of FDA Center for Devices and Radiological Health's (CDRH) Digital Transformation Initiative, several new tools have been released to strengthen the regulatory submission process. One of these tools is the Customer Collaboration Portal (CCP), which allows users to track...

    Read More
  • Impact of FDA Adoption of ISO 13485
    Quality System | Fda

    Impact of FDA Adoption of ISO 13485

    on 7 June 2022 | By Kevin Go, Project Engineer and Nancy Morrison, Executive Director Regulatory and Quality Consulting Services

    The FDA’s proposed rule to align its quality system regulation with ISO 13485 has the industry buzzing. What does it mean for medical device and IVD manufacturers? Let’s take a closer look at the proposed changes and what they might mean for manufacturers if they are adopted.

    Read More
  • FDA CDRH 2021: A Year in Review
    Fda

    FDA CDRH 2021: A Year in Review

    on 5 January 2022 | By Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer)

    Looking back to 2020, as the COVID-19 pandemic gripped the world, much of the FDA’s focus turned to their response to the public health emergency. CDRH in particular reviewed thousands of emergency use authorization (EUA) applications and worked to facilitate the development and...

    Read More
  • New Guidance: FDA Safer Technologies Program (STeP) for Medical Devices
    News

    New Guidance: FDA Safer Technologies Program (STeP) for Medical Devices

    on 21 January 2021 | By Kevin Go, MBA, RAC, CQA, RQM+ Senior Principal

    U.S. Food & Drug Administration (FDA) released the highly anticipated Safer Technologies Program (STeP) Guidance Document.

    Read More

We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!