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
    • Human Factors Research & Design
    • Business Process Services
    • Digital Applications: RAMS
    • Digital Applications: OPUS
    • Clinical Research
    • Privacy & Security Services
    Rams-Track logo

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

    LEARN MORE
    OPUS logo

    Emergo by UL's new human factors tool - provides training, tools, and resources.

    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

    • Saudi FDA postpones Unique Device Identification compliance deadlines

      The UDI compliance date depends upon risk class of the medical device

    • US FDA finalizes guidance on machine learning for medical devices

      The agency outlined the information required in premarket submissions

  • 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

    • Designing safe and effective instructional materials for medical devices

      July 07, 2022

      Get more details

    • Clinical data and post-market compliance under the MDR

      June 30, 2022

      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
Jun 23, 2022

Saudi FDA postpones Unique Device Identification compliance deadlines

The UDI compliance date depends upon risk class of the medical device

Read More
Jun 23, 2022

US FDA finalizes guidance on machine learning for medical devices

The agency outlined the information required in premarket submissions
Read More
Jun 20, 2022

Wiklund's Perspective: IFU designers--helping us get through the pandemic

The key role IFU play in the safety and effectiveness of at-home medical tests and technologies
Read More
Jun 17, 2022

MDR watch: European regulators urge greater compliance efforts to avoid medical device shortages

European MDCG downplays Article 59 as viable MDR transition compliance option
Read More
Jun 16, 2022

South Korea updates regulations on medical device codes and classification

MDFS issues updates to medical device and IVD regulations
Read More
Jun 16, 2022

Japan’s medical device regulators update PMD Act and the online submissions process

Manufacturers must now comply with updated procedures
Read More
Jun 13, 2022

China market update: Medical device regulators revise Clinical Trial Quality Management Regulation and various device-specific guidelines and technical review points

Chinese medical device market regulators provide clarity on new rules
Read More
Jun 9, 2022

US FDA withdraws COVID-era guidance for medical device and IVD market approval processes

Medical device manufacturers must prepare for full FDA registration process
Read More
Jun 8, 2022

New Swiss IVD regulations come into force as EU mutual recognition agreement expires

New Swiss IvDO shares many requirements with European IVDR
Read More
Jun 7, 2022

India’s medical device regulators adopt amendment regarding cancellation and suspension of licenses

Licensees must comply with Medical Devices (Third Amendment) Rules, 2022
Read More
Jun 2, 2022

Europe’s MDCG clarifies IVDR requirements for using medical tests in clinical trials

Certain medical tests used in clinical trials must comply with the IVDR.
Read More
Jun 1, 2022

Australia Market Update: TGA defines which digital mental health software it regulates

Digital mental health tools may be regulated as medical devices.
Read More
May 31, 2022

Considerations for post-HF validation design changes

An HFR&D framework for managing medical device design changes
Read More
May 27, 2022

ANVISA extends Brazilian Good Manufacturing Practice requirements to more medical device manufacturers

More medical device and SaMD manufacturing units now subject to BGMP certification rules
Read More
May 25, 2022

IVDR watch: New guidance from European MDCG ahead of date of application

Four new guidance documents from European regulators as IVDR comes into effect
Read More
May 24, 2022

IVDR Watch: European regulators add ISO 14971 to harmonized standards list

Risk management standard EN ISO 14791:2019 added to IVDR reference list.
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
© 2022 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.