Medical Devices Regulatory Expertise for MDs, IVDs and CDx
One Regulatory Road Map for Every Market
Proven regulatory advice, planning, and operational support for medical devices (MDs), in vitro diagnostics (IVDs), and companion diagnostics (CDx) across the EU, US, and Canada.
Regulations for Medical Devices (MD) and In Vitro Diagnostics (IVD), including Combination Products and Companion Diagnostics (CDx), are evolving across every major market. In Europe, a deep understanding of the new MD and IVD Regulations (MDR and IVDR) enables us to provide customized recommendations for optimal product development to successfully obtain the CE mark.
In the United States, Veristat supports MD and IVD manufacturers in obtaining FDA clearance or approval. Our regulatory experts guide you through pre-IDE meetings, IDE, De Novo, Breakthrough Device, 510(k), and PMA submissions. And because most device programs don't stop at one market, Veristat can extend that same regulatory support into Canada, helping you achieve an Investigational Testing Authorization (ITA) and Medical Device License (MDL) through Health Canada.
Veristat brings a team of scientific-minded regulatory experts who know how to build the technical documentation and regulatory strategy each market requires, so one program can move confidently across all three.
“The CE mark is the EU equivalent of FDA clearance or approval for Medical Devices, though the two follow different regulatory pathways and requirements."
That is why Veristat offers a team of scientific-minded regulatory experts who know how to develop the technical documentation and elaboration needed to support the CE mark certification.
One Road Map for Every Market
Developing a road map is critical to evaluate the regulatory and development requirements for a MD or IVD, and Veristat's regulatory experts help you build that road map across every market you're targeting.
Wherever your device is headed, Veristat brings the regulatory strategy, scientific judgment, and hands-on submission experience to get you there, so you spend less time navigating three different regulatory systems and more time getting your device or diagnostic to the patients who need it.
European Union
Obtain the CE mark under the European MDR and IVDR by assessing your device's classification, proposing a development strategy against the General Safety and Performance Requirements (GSPRs), scheduling the right interactions with Competent Authorities and European Notified Bodies, and defining the post-marketing activities your certification will require.
United States
Obtain FDA market authorization, whether through the 510(k), De Novo, or Premarket Approval (PMA) pathway, by assessing your device's classification, proposing a development strategy against the FDA's Quality Management System Regulation (QMSR), scheduling the right interactions with FDA through the Q-Submission program, and defining the post-market surveillance activities your clearance or approval will require.
Canada
Obtain a Medical Device License from Health Canada by assessing your device's classification under the Canadian Medical Devices Regulations, proposing a development strategy against the applicable Safety and Effectiveness Requirements, scheduling the right pre-submission interactions with Health Canada, and defining the post-market vigilance and problem reporting activities your license will require.
HOW IT WORKS
Building the Road Map
01
Classify.
Provide regulatory assessment and recommendations regarding the MD and IVD classification.
02
Strategize.
We propose a development strategy to comply with the General Safety and Performance Requirements (GSPRS), including an analysis of the available data and potential need for a clinical investigation.
03
Engage.
We schedule interactions with key Competent Authorities and Regulators - and select the right European Notified Body.
04
Plan Ahead.
We define post-marketing activities required under new Regulations.
From your road map to your final European Notified Body submission, here's what we bring to your MD or IVD certification.
Regulatory
Ensuring compliance with the MDR and IVDR regulations is essential to develop your MDs and IVDs. Our team of regulatory strategists and officers help you prepare the technical documentation to successfully attain certification and implement the correct maintenance processes, including:
-
Technical Documentation
The living document compiling all the information generated for a specific MD or IVD, submitted to a European Notified Body (NB) as the foundation of your certification package.
-
Risk Analysis (RA)
-
Clinical Evaluation Plan/Report (CEP/CER)
We support the full clinical evaluation process, from the Clinical Evaluation Plan (CEP), which defines the scope and methodology, through the systematic generation, collection, analysis, and assessment of clinical data verifying the device's safety and performance, compiled in the Clinical Evaluation Report (CER) as part of the Technical Documentation.
-
Clinical Investigation Plan/Report (CIP/CIR)
Our regulatory experts design and budget your Cclinical Investigations, backed by strategic consulting, biometrics, clinical operations, medical writing, and patient safety expertise, all under one integrated team from planning through execution.
-
Quality-Related Processes
We help establish the Risk Management Plan (RMP) and the Quality Management System (QMS) needed for each MD or IVD certification under MDR and IVDR.
-
Performance Evaluation Plan/Report for IVDs (PEP/PER)
he Performance Evaluation Report (PER) gathers and assesses all that information allowing demonstration of the clinical evidence. We assist companies in preparing the PER by delivering a literature search and choosing those studies considered supportive. Furthermore, our team can search for an equivalent IVD to explore its path to certification. We may also compile all the documentation and elaborate the PER for the Technical Documentation to be assessed by a European Notified Body.
-
Performance Study (IVD)
We help design the Performance Studies needed to confirm your IVD’s analytical and performance that support its intended purpose.
-
Post-Market Clinical Follow-up Plan/Report (PMCF Plan/Report)
Medical Writing for MDs/IVDs.
MD regulations don't follow the same playbook as pharmaceutical regulations, and treating them the same way is where compliance gaps start. Our Medical Writing team works directly alongside our regulatory experts, bringing real, specific experience preparing the documents MD and IVD requirements actually call for, including:
-
Clinical Iinvestigation Plans and Reports (CIP/CIR)
-
Clinical Evaluation Plans/Reports (CEP/CER)
-
Medical Device publications
Regulatory Gap Analysis
A Gap Analysis is intended to examine and identify the differences between the current state of development of the MD and IVD and what the situation should be to ensure certification is obtained.
Conducting a Gap Analysis will help to improve your development process efficiency by allowing the identification of gaps, and to help define the objectives and needs that will allow your product to transition to the required end goal (e.g. enter into clinical stage, fulfill the clinical evaluation, obtain the CE mark, etc.).
Regulatory Expertise for MDs, IVDs and CDx
Cross-functional by design, not by request.
Clinical Iinvestigations for your MD or IVD don't sit with one team, they draw on strategic consulting, biometrics, clinical operations, Medical Writing, and patient safety expertise, working as one integrated group from design through execution.
We know the exceptions, not just the rules.
Class III and implantable devices generally require a Clinical Investigation, but exceptions exist, and knowing which ones apply to your product can save real time and cost.
IVD equivalence, not just IVD data.
When preparing a Performance Evaluation Plan/Report, we don't just analyze your own data, we can identify an equivalent IVD already on the market and explore its path to certification as a strategic option for yours.
A regulatory landscape that's still being written.
MDR and IVDR continue to evolve, and staying current with them, not just compliant with where they stood last year, is what keeps your certification strategy from going stale.
NEXT STEPS
What's Next in the Drug Development Process
Clinical Investigation & Evaluation.
Generate the clinical data your classification and risk profile require, from investigation design through execution.
Biostatistics.
Statistical planning and analysis supporting your clinical investigation and evidence generation strategy.
Regulatory Submission.
Move from Technical Documentation and road map to a complete, submission-ready package for your Notified Body, FDA, or Health Canada.
Give your data a clear regulatory direction.
Your clinical and performance data should do more than demonstrate what your device or IVD can do. Veristat helps you understand what the evidence means for your regulatory strategy, identify what may still be needed, and define the decisions that move your program toward its next milestone.
Frequently Asked Questions
Under MDR, Class III and implantable Medical Devices generally require a Clinical Investigation to evaluate safety and performance, though exceptions can apply depending on the specific device and its regulatory pathway.