Medical Device Regulatory Services

Emergo by UL

Emergo by UL offers comprehensive regulatory consulting and market access services for medical devices and IVDs globally. They specialize in device registration, human factors, privacy, and security, helping clients navigate complex international compliance requirements.

Emergo by UL is a leading provider of regulatory consulting and market access services for medical device and IVD companies worldwide. With a deep understanding of global regulatory landscapes, they assist clients in achieving compliance and facilitating market entry across various regions. Their core services include medical device registration, in-country representation, and post-market surveillance. They also offer specialized expertise in human factors research and design, ensuring products are safe and effective for end-users. Furthermore, Emergo by UL provides crucial privacy and security consulting, addressing data protection requirements like HIPAA and GDPR. Leveraging a suite of digital tools and extensive industry knowledge, Emergo by UL helps streamline regulatory affairs and quality assurance activities. They are dedicated to supporting manufacturers throughout the entire product lifecycle, from initial development to global market access, ensuring a smooth and compliant journey.

About

**Who they are**
Medical Device Regulatory Services (MDRS) is a provider of dispute resolution services, specializing in mediation and arbitration. They offer a full range of out-of-court services to private individuals, attorneys, businesses, government agencies, and the insurance community.

**Expertise & scope**
* Provides mediation services where parties agree on an impartial mediator to hear dispute facts and positions, with typically high settlement rates (90-95%).
* Offers arbitration services where parties choose an impartial arbitrator to conduct a hearing, present evidence, and render a final, legally binding decision.
* Facilitates Med/Arb, a combined process where mediation is followed by binding arbitration if the dispute remains unresolved.
* Specializes in Foreclosure Mediation, acting as a Program Manager to help homeowners and lenders negotiate alternatives to foreclosure.
* Conducts Case Evaluation, where a neutral evaluator provides an opinion on the likely outcome of a case if adjudicated, aiming to encourage settlement.

**Reputation / proof points**
* Massachusetts Dispute Resolution Services (MDRS) was the sole designated Program Manager for the City of Lynn, Massachusetts’ Foreclosure Mediation Program during its active period in 2014/15.

Additional information

MDRS emphasizes the flexibility and efficiency of Alternative Dispute Resolution (ADR) processes, which are designed to be more economical and less time-consuming than traditional litigation. They highlight that ADR methods can be tailored to the specific circumstances and preferences of the disputing parties. The organization provides resources such as an ADR Users Guide, Arbitration Rules, Mediation Guidelines, and various forms to assist parties in navigating these processes. Their services aim to increase satisfaction and preserve relationships by focusing on collaborative solutions rather than adversarial outcomes.

Key Highlights

  • Offers a full range of out-of-court mediation and arbitration services. Source
    “Massachusetts Dispute Resolution Services (MDRS) provides a full range of out-of-court mediation and arbitration services”
  • Mediation settlement rates are typically very high, with 90-95% of disputes reaching settlement. Source
    “Mediation settlement rates are typically very high, with 90-95% of disputes reaching settlement”
  • Provides specialized Foreclosure Mediation services. Source
    “The goal of foreclosure mediation is to enable homeowners and lenders to communicate and negotiate”
  • Conducts Case Evaluation, providing a neutral opinion on case outcomes to encourage settlement. Source
    “Case evaluation is a process where the parties agree to present a summary of their case to a neutral evaluator”

Certifications & Trust Signals

  • Served as the sole designated Program Manager for the City of Lynn, Massachusetts’ Foreclosure Mediation Program in 2014/15. Source
    “Massachusetts Dispute Resolution Services [MDRS] was the sole designated Program Manager for the City of Lynn, Massachusetts’ Foreclosure Mediation Program during its active period in 2014/15.”

Buyer Snapshot

Best for
  • Parties seeking alternatives to court litigation
  • Businesses and individuals needing to resolve disputes efficiently
  • Homeowners facing foreclosure
How engagement typically works
  • Facilitated negotiation
  • Formal arbitration hearings
  • Case evaluation for settlement guidance
Typical deliverables
  • Mediation agreements
  • Arbitration awards
  • Case evaluation reports
  • Settlement agreements
Good to know
  • Best when parties are willing to engage in negotiation or arbitration.
  • Foreclosure mediation requires responsiveness to program requirements.

Pricing

Model: Custom pricing
HQ: St. Louis, US
Languages: English, French, German, Spanish
Timezones: GMT, EST
Status: listed

Services & Capabilities

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Jurisdictions: US
Countries: US
Industries: Medical Devices, Pharmaceuticals, Biotech, IVD, Food & Beverage
Onboarding time: 3–14 days
Pricing model: Custom pricing
Registration Support: Yes
Product Type: devices

Additional us_agent_fda Details

Product Types
Dispute Resolution Services
Registration Support
No
Recall Support
No
Inspection Support
No
Emergency Contact24x7
No
US Entity State
MA
Onboarding Steps
Parties agree on an impartial mediator/arbitrator, present case summaries or evidence, and engage in negotiation or formal hearings. Specific steps for foreclosure mediation involve program managers and loan counselors.
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