Skip to main content

Search form

Close
  • Industry Focus

    Industry Focus

    The healthcare industry is changing and we have the breadth of expertise to help you evolve with it. View All

    • MedTech
    • HealthTech
    • Pharmaceuticals / BioTech
    • Healthcare Providers
    • Health & Wellness Retail

    We have deep expertise with a range of product types, including combination and borderline products.

  • Services

    Services

    Comprehensive service offerings at every point in the product life cycle.

    • Market Access
    • Digital Health & Cybersecurity
    • Business Process Services
    • Human Factors Research & Design
    • Clinical Research
    • Digital Applications: RAMS
    Rams-Track logo

    A platform of digital products to improve, simplify and automate RA/QA activities

    LEARN MORE
  • Blog

    Blog

    The latest industry news and insights from our global team. View All

    • Market Access
    • Digital Health & Cybersecurity
    • Business Process Services
    • Human Factors Research & Design
    • Clinical Research

    Featured

    • US FDA ramping up permanent 510(k) exemptions for dozens of low-risk medical devices

      Permanent exemptions from 510(k) requirements proposed for several devices as FDA focuses on COVID-19 public...

    • TGA carves out exemptions for some software-based medical devices

      The listed products, including both physical devices and software as a medical device (SaMD), will...

  • Resources

    Resources

    Resources and tools tailored to medical device professionals. View All

    • Market Data
    • Webinars
    • White Papers
    • Process Charts
    • Videos
    • Device Regulations
    • Tools

    MDR Resource Center

    The knowledge you need for MDR implementation

    Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. Meet our MDR team and get free educational resources on the MDR.

  • Events

    Events

    Learn from our experts through live events. View All

    Types

    • Webinars
    • Workshops
    • Tradeshows
    • Other

    Related Service

    • Market Access
    • Digital Health & Cybersecurity
    • Human Factors Research & Design

    Upcoming

    • Marketing medical devices in the post-Brexit era: Working with a UK Responsible Person (UKRP)

      Feb 18, 2021

      Get more details

    • Threshold Analyses: Inspecting for User Interface Differences

      Jan 28, 2021

      Get more details

  • About

    About

    Our global consulting team works from 20+ offices on six continents. View All

    • News
    • Certifications
    • Careers
    • Locations

    US Location

    • Emergo by UL Global Headquarters
    • 2500 Bee Cave Road
      Building 1, Suite 300
      Austin Texas 78746
      +1 512 222 0262
    • ALL LOCATIONS
  • Contact
  • Subscribe

Search form

Close

Questions? Request more information from our specialists

CONTACT US
  1. Home
  2. Blog
  • Pg
Jan 25, 2021

US FDA ramping up permanent 510(k) exemptions for dozens of low-risk medical devices

Permanent exemptions from 510(k) requirements proposed for several devices as FDA focuses on COVID-19 public health emergency

Read More
Jan 22, 2021

TGA carves out exemptions for some software-based medical devices

The listed products, including both physical devices and software as a medical device (SaMD), will not be listed on the Australian Register of Therapeutic Goods (ARTG) or subject to regulatory scrutiny by the TGA.
Read More
Jan 19, 2021

Chinese regulators announce classification adjustments and UDI submission guidelines

The NMPA made revisions to its medical device classification catalog including the down-classification of 15 device types, while a CMDE announcement accompanied the end of the UDI pilot program and the beginning of compliance enforcement for some devices.
Read More
Jan 18, 2021

New Brazil INMETRO ordinance eases inspection and documentation requirements

Ordinance No. 384/2020 allows for alternatives to on-site inspections, removes issuance data requirements for test reports, and makes INMETRO certificates valid indefinitely as long as maintenance audits are performed.
Read More
Jan 15, 2021

US FDA unveils next steps for regulating artificial intelligence-based medical software

FDA rolls out evolving regulatory approach for AI/ML-based software as a medical device (SaMD)
Read More
Jan 13, 2021

European Commission announces appointments to medical device, IVD Expert Panels

Expert panelists appointed across 12 sectors for EU MDR, IVDR support
Read More
Jan 13, 2021

Home Healthcare Products Take Center Stage

User interface design and safety issues for medical device designers as home healthcare products become more common
Read More
Jan 13, 2021

Canadian regulatory amendments introduce expanded post-market surveillance provisions

Health Canada published changes to the Medical Devices Regulations (CMDR) that will empower regulatory authorities and place greater emphasis on the life cycle of medical devices.
Read More
Jan 12, 2021

US FDA finalizes guidance on Safer Technologies Program

STeP is modeled after the Breakthrough Devices Program and offers support for medical devices and combination products that aim to improve safety of current treatments and diagnostics.
Read More
Jan 12, 2021

Mitigating the Risk Posed by Open and Obvious Hazards

Obvious use risks posed by medical devices and products must still be mitigated against by product developers and designers
Read More
Jan 12, 2021

Design with the end user in mind

Keeping the user experience centered during the early stages of designing a medical device can help you to optimize healthcare outcomes and avoid use issues down the line.
Read More
Jan 6, 2021

US FDA provides extra response time for device submissions on hold and expands virtual options

An updated guidance document extends the deadline for companies to deal with applications and submissions placed on hold during the COVID-19 pandemic, while virtual advisory committee meetings and additional alternatives to on-site MDSAP audits will be available.
Read More
Jan 5, 2021

Health Canada explains plans for COVID-19 Interim Orders and forthcoming regulatory amendments

The agency plans to maintain continuity and ensure a blend of flexibility and regulatory oversight as it transitions to longer-term transition measures for combating the pandemic.
Read More
Jan 5, 2021

UK MHRA issues post-Brexit medical device, IVD registration requirements

UK MHRA registration requirements and compliance grace periods for medical devices and IVDs
Read More
Dec 22, 2020

New Croatian Notified Body designated to European MDR

UDEM becomes eighteenth Notified Body designated under the European Medical Devices Regulation (MDR)
Read More
Dec 22, 2020

TÜV Rheinland is fifth Notified Body designated under EU IVDR

The German organization is now listed in the NANDO database, but concerns remain about whether there will be a sufficient number of Notified Bodies to handle the workload in 2022.
Read More
  • Pg
Industry Focus
  • MedTech
  • HealthTech
  • Pharmaceuticals / BioTech
  • Healthcare Providers
  • Health & Wellness Retail
Services
  • Market Access
  • Human Factors Research & Design
  • Digital Health & Cybersecurity
  • Clinical Research
  • Business Process Services
  • Digital Applications: RAMS
  • Blog
  • Resources
  • About
  • Office Locations
  • Let's connect
  • Language
  • Subscribe
  • Join the RADAR Newsletter
  • Join the TalkingPoints Newsletter
© 2021 EMERGO by UL. All Rights Reserved. Privacy Terms of Use Data Subject Access Request Portal

Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.