##  [Regulatory Readiness and Compliance for Health and Life Sciences](/services/regulatory-readiness-and-compliance-health-and-life-sciences) 

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# Regulatory Readiness and Compliance for Health and Life Sciences

 

Our consulting and software help customers navigate complex regulatory requirements and access global markets with confidence*. 

  [ Contact us ](#form)  

 

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  ## Mitigate regulatory challenges for seamless market access



Health and life sciences companies are challenged to comply with complex and constantly evolving regulations worldwide. Lack of automation, well-thought-out market access strategies and local expertise can hinder market access. We provide a global network of experts to support compliance and software to automate regulatory affairs\*.





 

 

 

 

  

   Close *cancel* ### Leverage our regulatory expertise



Achieve and maintain medical market access.

 

 

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    I agree to receive UL Solutions marketing communications and understand that I can opt out at any time without affecting other services by visiting our [Preference Center](https://www.ul.com/preference-center).



  

 

 

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   ![Hand with medical symbol](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/hand_with_medical_symbol.svg)### Leverage our global medical market expertise

Our consulting team provides medical market expertise in more than 20 countries\*.



 

 

   ![Document check mark](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/document_check_mark.svg)### Simplify product registration

Our consultants have helped register more than 100,000 medical products worldwide\*.



 

 

   ![Medical computer](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/medical_computer.svg)### Automate regulatory compliance

Manage compliance with our software, used by 15,000+ medical device and IVD companies.



 

 

 

 

  ## How we enable customers to navigate regulatory landscapes



 

 

 

   ![Safety science](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/safety_science.svg) 

### Medical Device and IVD Regulatory Affairs and Quality Consulting

The Emergo by UL team of regulatory affairs experts helps medical device and IVD companies achieve their market access goals and maintain post-market compliance in more than 20 countries\*.



 

  [ Learn more *arrow\_forward* ](https://www.emergobyul.com/services/medical-device-and-ivd-regulatory-affairs-and-quality-consulting) 

 

 

   ![Hand holding document](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/hand_holding_document.svg) 

### Global Registration Consulting for Medical Devices and IVDs

Medical market access requires registering products with regulators. Our experts help customers prepare application materials, build quality management system compliance and register their devices worldwide\*.



 

  [ Learn more *arrow\_forward* ](https://www.emergobyul.com/services/device-registration) 

 

 

   ![Hand holding person](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/hand_holding_person.svg) 

### In-country Representation for Medical Device Manufacturers

Companies must appoint an in-country representative in each of their target markets to manage compliance. We provide regulatory expertise and represent more than 2,000 medical device and IVD companies in more than 15 countries\*.



 

  [ Learn more *arrow\_forward* ](https://www.emergobyul.com/services/local-authorized-representative-medical-device-manufacturers) 

 

 

   ![Building with columns and information circle](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/building_with_columns_and_information_circle.svg) 

### Regulatory Affairs Management Suite (RAMS®)

Emergo by UL offers the Regulatory Affairs Management Suite (RAMS) SaaS platform, enabling customers to automate regulatory affairs processes and leverage our regulatory intelligence across multiple markets\*.



 

  [ Learn more *arrow\_forward* ](https://www.emergobyul.com/software/regulatory-affairs-management-suite) 

 

 

   ![Eye](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/eye.svg) 

### Medical Device Post-Market Surveillance

Regulators in most medical device markets require registrants to meet post-market surveillance (PMS) obligations to maintain compliance. Emergo by UL supports PMS compliance in multiple markets\*.



 

  [ Learn more *arrow\_forward* ](https://www.emergobyul.com/services/medical-device-post-market-surveillance) 

 

 

   ![Molecules](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/molecules.svg) 

### ULTRUS® ChemADVISOR® Regulatory Database

Companies managing environmental, health and safety (EHS) regulatory compliance can use our ULTRUS ChemADVISOR Regulatory Database, which provides chemical regulatory data on 600,000+ substances.



 

  [ Learn more *arrow\_forward* ](/software/ultrus/chemical-regulatory-database) 

 

 

   ![Technical report](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/technical_report.svg) 

### ULTRUS® WERCS Studio Chemical Data and Compliance Management

Our ULTRUS WERCS Studio software enables chemical and material data management for compliance, product transparency and sustainability. WERCS Studio uses regulatory data from our ChemADVISOR database.



 

  [ Learn more *arrow\_forward* ](/software/ultrus/chemical-data-compliance-management) 

 

 

   ![2 people talking](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/2_people_talking.svg) 

### Chemical Regulatory Advisory Services

We provide expert advisory support to help customers achieve compliance. Our network of experts collaborates with customers to identify chemical compliance actions, create compliance documents and more.



 

  [ Learn more *arrow\_forward* ](/services/chemical-regulatory-advisory-services) 

 

 

 

 

 

 

   ## Meet our experts



 

 

 

 

    

“A well-thought-out regulatory strategy can enable innovation, streamline market access and position your business for sustained growth.”

 

  [ Learn about Evangeline *arrow\_forward* ](/about/people/evangeline-loh)  

  ![Evangeline Loh](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:57d5cb8f-1423-47c9-a075-22aa8a1aa8b1/as/57d5cb8f-1423-47c9-a075-22aa8a1aa8b1.webp?&smartcrop=Square&max-quality=90&width=400) 

 

### Evangeline Loh

 Senior Manager, Quality & Regulatory Affairs 

 

 

 

 

 

   

“We are proud to serve as a trusted resource to help our customers achieve regulatory compliance, working together to make the world a safer place.”

 

 

  ![Jennifer Turner](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:899e236e-40e7-4285-8556-6502d6d66a85/as/899e236e-40e7-4285-8556-6502d6d66a85.webp?&smartcrop=Square&max-quality=90&width=400) 

### Jennifer Turner

 Senior Regulatory Affairs Manager, Product Stewardship | Software & Advisory 

 

 

 

  [ Learn about Jennifer *arrow\_forward* ](/about/people/jennifer-turner)  

 

 

 

   ## Related regulatory readiness and compliance resources



 

 

 

   ![Information circle](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/information_circle.svg)

### EU MDR Readiness Assessment Checklist

Use this short checklist to assess what your medical device company needs to do to comply with the EU MDR.



 

  [ Download guide *arrow\_forward* ](https://www.emergobyul.com/resources/eu-mdr-readiness-assessment-checklist)  

  

 

   ![Video](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/video.svg)

### Optimization for Global Vigilance Reporting

Learn more about optimization for global vigilance reporting.



 

  [ Watch webinar *arrow\_forward* ](https://www.emergobyul.com/resources/optimization-global-vigilance-reporting)  

  

 

   ![Document](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/document.svg)

### PFAS Compliance White Paper

Download our white paper, PFAS Regulations and Strategies for Compliance, to learn more about supply chain challenges and opportunities.



 

  [ Get white paper *arrow\_forward* ](/insights/pfas-compliance-white-paper)  

  

 

   ![Document](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/document.svg)

### Global Regulatory Compliance for Medical Devices

Our white paper covers developing regulatory strategies for accessing multiple medical markets.



 

  [ Get white paper *arrow\_forward* ](https://www.emergobyul.com/resources/global-regulatory-compliance-medical-devices)  

  

 

 

 

 

 

   ### Enabling safety, compliance and sustainability for health and life sciences innovators



Our safety science expertise and software enable industry innovators to streamline market access, manage cybersecurity risks, build a compliant workforce, enhance supplier risk management and strengthen ESG management capabilities, helping them develop safer and compliant medical products and systems. Download our brochure to learn more.





 

 

 

   PDF ### Health and life sciences brochure

HLS brochure introduces UL Solutions' offerings for the Health and Life Sciences (HLS) industry. It showcases five key solution pillars—Market Access, Cybersecurity, Workforce Training & Competence, Supply Chain Resilience, and ESG stewardship—each addressing critical industry challenges and our value proposition. Designed for awareness and consideration stages, this brochure targets Medtech innovators, medical device manufacturers, and HLS decision makers. Ideal for digital campaigns, sales enablement, and industry events.

 

  [ Download PDF *download* ](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:ff1d8944-a0a7-4678-bec7-901aca72e572/original/as/GI24CS1986595-_HLS_Campaign_Brochure.pdf) 

 

 

 

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## Leverage our regulatory expertise

Achieve and maintain medical market access.



  [ Contact us ](#form)  

  

 

 

  ## Related Health and Life Sciences market access offerings



 

 

 

   ![Modern Hospital Physical Therapy: Patient with Injury Walks on Treadmill Wearing Advanced Robotic Exoskeleton Legs. Physiotherapy Rehabilitation Technology to Make Disabled Person Walk. Focus on Legs](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:a3fd0126-4bae-4f11-8d02-4295b46b9d40/as/a3fd0126-4bae-4f11-8d02-4295b46b9d40.webp?&max-quality=90&width=400) 



### Product and Process Development for Health and Life Sciences

 

  [ Learn more ](/services/product-and-process-development-health-and-life-sciences)  

 

 

   ![Technological Prosthetic Robot Arm is Tested by Two Professional Development Engineers in a High Tech Research Laboratory with Modern Futuristic Equipment. Compare Data on a Personal Computer.](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:2dfde43c-35c1-4258-a0c9-e2b884195e77/as/2dfde43c-35c1-4258-a0c9-e2b884195e77.webp?&max-quality=90&width=400) 



### Testing and Certification for Health and Life Sciences

 

  [ Learn more ](/services/testing-and-certification-health-and-life-sciences)  

 

 

 

 

   ## Comprehensive offerings for the Health and Life Sciences industry



 

 

 

   ![Royalty-Free Stock Photography by Rubberball.com](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:7e8510b7-9150-49cc-bbaa-d8f8a6c1f2b2/as/7e8510b7-9150-49cc-bbaa-d8f8a6c1f2b2.webp?&max-quality=90&width=400) 



### Market Access for Health and Life Sciences

 

  [ Learn more ](/services/market-access-health-and-life-sciences)  

 

 

   ![Over the shoulder view of a female doctor looking at brain x-ray images of male patient undergoing MRI in background at hospital. Neurologist examining patient's CAT scan images on digital table in clinic.](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:94f3d57a-a037-456e-9f17-ab4418229903/as/94f3d57a-a037-456e-9f17-ab4418229903.webp?&max-quality=90&width=400) 



### Cybersecurity for Health and Life Sciences

 

  [ Learn more ](/services/cybersecurity-health-and-life-sciences)  

 

 

   ![Online Webinar Meeting At Chemical Plant. Videoconferencing](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:524edf34-618d-47ee-aec3-9d8d1720feab/as/524edf34-618d-47ee-aec3-9d8d1720feab.webp?&max-quality=90&width=400) 



### Workforce Training and Competence for Health and Life Sciences

 

  [ Learn more ](/services/workforce-training-and-competence-health-and-life-sciences)  

 

 

   ![Green Cargo Container Ship, Cargo Container only green color. container ship running in the ocean to shipyard sea port. import shipping industry freight logistics. Concept green transportation environment](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:caa056cb-3c47-45d3-823e-52d4d5da7912/as/caa056cb-3c47-45d3-823e-52d4d5da7912.webp?&max-quality=90&width=400) 



### Supply Chain Resilience for Health and Life Sciences

 

  [ Learn more ](/services/supply-chain-resilience-health-and-life-sciences)  

 

 

   ![Closeup group Asia businesspeople talk ESG strategies risk management workshop night, SDGs, global warming, green finance and investment and net zero waste lifestyle in boardroom training building.](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:97f47c2c-7246-4252-a497-45a9d87311e9/as/97f47c2c-7246-4252-a497-45a9d87311e9.webp?&max-quality=90&width=400) 



### ESG Stewardship for Health and Life Sciences

 

  [ Learn more ](/services/esg-stewardship-health-and-life-sciences)  

 

 

 

   *\* Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/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 brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR, **IVDD or IVDR Notified Body**, UKCA MD Approved Body or MDSAP Customers.*