Regulatory Consulting
EU MDR Consulting Services
Prior to the European Medical Device Regulation (EU MDR) being implemented in 2021, the EU was a relatively simple market for manufacturers to enter. EU MDR introduces new challenges when compared to the previous directives, from clinical evidence, labelling, quality assurance, marketing, distribution, and more. GLOBAL’s team of consultants can help you navigate the new requirements and ensure that you are prepared for your upcoming MDR submissions.
EU MDR Gap Assessments
Gap assessments are an integral tool to ensure compliance is reached for EU MDR. Whether you are tackling IFU Requirements (Annex I Chapter III), CER/PMCF requirements (Annex XIV), or PMS documentation requirements (Annex III), we can help you build a plan for compliance.
EU MDR Procedures and Templates
The EU MDR requirements should be built into a manufacturer’s QMS by way of procedures and templates; this is vital to gaining an MDR QMS certification and to guarantee ongoing MDR compliance. GLOBAL has the expertise to build you a compliant system of MDR-compliant standard operating procedures and can provide you pressure-tested templates to use for your future submissions.
Clinical Evidence & PMCF Strategy
With more stringent regulatory requirements has come a greater focus on clinical data sufficiency for medical devices. GLOBAL's consulting team can help you determine if your clinical evaluation strategy is appropriate and if your levels of clinical evidence and PMCF meet the criteria for data sufficiency. If you do not have a strategy, we can help you build one.
MDR Document Remediation Plans and Schedules
Reaching compliance with EU MDR requires strategic planning and appropriate tracking of the remediation. Managing the additional requirements across multiple product families and technical files can become a complex task. A proper project plan will guide your team and help you project resourcing needs. GLOBAL can build and managing this system and schedule for you and can working directly with your writing team to ensure a smooth execution.
Notified Body Response Strategy and Execution
Responding to your notified body should be a calculated strategy based on the MDR requirements and guidance. Correspondence with the notified body has to be deliberate and performed by someone well-versed in writing notified body responses. GLOBAL's consultants have the expertise to support you building and executing a plan to close non-conformities. GLOBAL can support you by writing responses, reviewing already written responses, and/or performing remediation resulting from correspondence with the notified body.
Clinical Development Planning and Strategy
When developing a new product under EU MDR, clinical evidence must be considered early in product development to ensure sufficient clinical evidence will be available at the time of certification. By writing the Clinical Development Plan or simply providing cross-functional support along the way, GLOBAL's consulting team can support you in finding efficient methods to collect data prior to entry in the EU market.
Live EU MDR Education and Training
Attending a tailored EU MDR training is an excellent way to ensure your cross-functional team is aware of the requirements that apply to your medical devices. The topics presented can be hand-picked to ensure that we focus on your team’s needs. Once the topics are picked, we will schedule a live virtual training presented by one of our MDR experts.
FDA Regulatory Strategy and Submissions
Entering the US market can feel overwhelming without the proper preparation and knowledge. Having GLOBAL as a strategic partner can ease the process and we can take on as much responsibility of the submission as needed. Whether you have one submission or would like to build a pipeline of submissions over time, GLOBAL can help you build a plan for strategic execution.
GLOBAL's team of consultants have experience with 510k, PMA, and IDE submissions and can provide guidance or prepare the full submissions for you.