Services EU MDR and IVDR Compliance Support

Get access to the experts and project support you need to plan and execute department, site, or company-wide activities necessary to meet the European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements.

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EU MDR & IVDR Services Need expert help transitioning into EU MDR and IVDR compliance?

In recent years—and increasingly as deadlines draw near—The FDA Group has helped a wide range of medical device companies efficiently and effectively transition into EU MDR compliance with the help of experienced regulatory experts.

The May 26, 2021 deadline for the MDR has now passed, and the regulation is now being applied after a year-long delay. But we know many organizations still need expedited transition assistance, especially as the pandemic has affected preparations to meet deadlines.

These regulations bring significant changes for risk management, clinical evaluation, operating controls including those for suppliers, general safety and performance requirements (GSPR), labeling, post-market surveillance, and other processes. Simply put, manufacturers must address these areas immediately.

We can help with MDR compliance and help you meet the IVDR, which is now set for May 22, 2022.

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Our services We can help accelerate compliance readiness—no matter where you are in transition.

The FDA Group's EU MDR and IVDR compliance support services include, but are not necessarily limited to:

  • Regulatory compliance gap assessments 
    • Get a full or partial assessment of your quality system including all technical documentation
  • Quality Management System (QMS) Assessments for EU MDR & IVDR Compliance
    • Using (ISO 13485:2016 as a standard, we can help assess documentation and processes such as SOPs for necessary changes required to manage EU MDR, including UDI.
  • Assessment for Devices with Valid MDD/AIMD Certificates
  • Assessments for Class I devices and systems and procedure packs that must be EU MDR compliant by 2020
  • Transition/compliance plan development
    • On-site or remote
  • Transition/compliance plan execution
    • On-site or remote
  • Knowledge transfer
  • File and document maintenance
  • Long-term staff augmentation support as needed

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Area of expertise Work with experienced EU MDR & IVDR compliance experts.

The FDA Group's EU MDR and IVDR team has helped many medical device and diagnostic companies—of all sizes—understand these regulations front to back and implement an efficient, comprehensive, and demonstrable approach to compliance.

Whether you need full-service support to develop and execute a compliant regulatory strategy or simply need to augment your internal resources additional expertise to manage specific complexities. The FDA Group Validant will deliver the skills and experience you need, when and where you need it.

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Engagement Models

 

Get access to expert consultants as well as contingent or direct hire candidate search and placement services. We specialize in the entire range of the resourcing process, giving you a breadth of expertise that has become increasingly hard to find in the life science industry.

ENGAGEMENT MODEL Consulting Projects

Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.

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ENGAGEMENT MODEL Staff Augmentation

Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.

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Why work with The FDA Group?

 
  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

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Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • Recruiting Team External Search
  • In-House Subject Matter Experts
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management For Client
  • Total Quality Guarantee

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of regulatory requirements, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.


Please contact us to learn more about fulfilling specific EU MDR and/or IVDR needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.