Regulatory Solutions for Medical Devices & Diagnostics

Global Regulatory Consulting

Our team of seasoned experts assist in all matters concerning the regulation and compliance of your medical device or combination product. At each step in the development of your medical device, you will gain new information and data that will construct and change the steps that follow. As this happens, your regulatory strategy will transform as well. We work with you to integrate any new information into your overall plan, even if we didn’t develop the initial strategy. We will audit and adjust your regulatory strategy to optimize the pathway to approval for your medical device.

ProPharma has a full range of consulting capabilities across the globe, including all-inclusive regulatory consulting services for medical devices, diagnostics, and combination products. Our medical device consulting capabilities include all regulatory, clinical and quality compliance aspects of device, diagnostic, and combination product development. We have experience with medical devices across all classes and spanning a diverse range of indications and therapeutic areas. Our emphasis on science, coupled with the technical expertise of our medical device experts, allows us to effectively communicate with regulatory authorities in support of your product.

Regardless of where you are in the development, approval or commercialization of your medical device, we can help. We take a proprietary approach to strategy development, combining deep and broad scientific knowledge with extensive regulatory, clinical and quality experience. This method has proven successful for decades, as we have assisted our clients in achieving regulatory approvals for more than 23 years.

FDA Regulatory Consulting Services

Our team provides expert FDA regulatory consulting services for medical device companies, leveraging the experience of former FDA officials, industry executives, and scientific experts to accelerate development and ensure compliance. Our medical device-specific FDA regulatory consulting services include:

FDA Regulatory Strategy:

We work with organizations to define the optimal FDA regulatory pathway—whether 510(k), De Novo, or PMA—based on the unique attributes of their product. Our team builds dynamic, data-driven strategies that adapt as new information emerges during development.

FDA Meeting Support:

We ensure productive interactions with FDA by providing end-to-end support for Q-Submissions (q-subs), IDE discussions, and Advisory Committee meetings. Our experts guide the preparation of briefing packages, rehearse responses, and represent clients during meetings to help achieve clear, actionable outcomes.

FDA Submissions

We deliver full-service support for all FDA submission types, including:

• 510(k) Premarket Submission: predicate assessment, testing guidance, submission compilation
• De Novo: risk-based classification, benefit-risk rationale
• PMA: clinical study design, IDE support, PMA modules
• IDE, Breakthrough Device, and HUB submissions

Our team of regulatory consultants assist with classification, testing plans, content development, submission formatting, and regulatory responses to ensure high-quality, compliant applications.

With more former-FDA colleagues than anyone else as well as an extraordinary team of industry executives and regulatory experts, we know exactly what the Agency is looking for in an application and have the resident knowledge needed to help you obtain the desired outcomes from FDA.

Preclinical and Biocompatibility Testing: our team designs and manages preclinical testing programs that align with FDA and ISO expectations. This includes:

• Biocompatibility assessments
• Bench and performance testing
• Electrical safety
• Software validation
• Human factors engineering
• Sterilization
• Animal studies (where applicable)

Reimbursement and Market Access

Understanding that FDA approval doesn't guarantee market success, ProPharma integrates reimbursement and market access planning into the regulatory strategy. We help clients secure coverage, coding, and payment pathways that support product adoption and commercial viability. Our services include:

• Medicare and payer coverage
• CPT/HCPCS code development
• Payment pathways and pricing strategy

Postmarket Regulatory Compliance

We support ongoing compliance with postmarket FDA requirements, including medical device reporting, labeling and promotional oversight, post-approval studies, and recall management. We also assist with FDA inspections and global regulatory expansion.

European Medical Device and Diagnostic Development

Our team of local European medical device experts offers comprehensive regulatory consulting services to help medical device and IVD manufacturers successfully navigate the European regulatory landscape, including MDR and IVDR requirements. Our team of regulatory consultants have extensive expertise in both medical devices and diagnostics and provide clients with end-to-end support across the entire product lifecycle, including:

• Regulatory Strategy & CE Marking: we provide tailored strategies to streamline conformity assessment, classification, and documentation aligned with MDR/IVDR and harmonized standards.
• Regulatory Meetings: our team assists with the preparation and strategic support for interactions with National Competent Authorities and Notified Bodies, including briefing documents and meeting coaching.
• CE Marking Submissions: we offer full-service support for technical documentation, clinical/performance evaluations, GSPR checklists, labeling reviews, and Notified Body engagement.
• Preclinical Testing: our experts design and manage biocompatibility, electrical safety, software validation, and usability testing per ISO and IEC standards.
• EU Reimbursement & Market Access: we partner with clients to develop market-specific payer strategies, HTA submissions, early access programs, pricing strategy, and health economic value propositions.
• Postmarket Surveillance & Compliance: we assist with PMS and PMCF/PMPF planning, incident reporting, CAPA, audit readiness, and regulatory intelligence aligned with MDR/IVDR.

Our team provides comprehensive consulting to support medical device and IVD manufacturers seeking market access and compliance in Great Britain under the UK’s post-Brexit regulatory regime.

Digital Health

Software Functions and SaMD

ProPharma's industry-leading MedTech professionals provide guidance on software-related questions to support clients of all sizes. We partner with you to ensure delivery of documentation that meets regulatory expectations and facilitate successful premarket submissions.

Software products are used in a variety of healthcare applications including tracking personal health and well-being, monitoring vital signs, administering therapies, facilitating diagnoses and treatment decisions, and aiding with surgical procedures. Our experts can advise on how to determine whether a software function and/or product meets the definition of a medical device (SaMD or SiMD) that is subject to FDA regulatory oversight. We can also lead strategies for potential pathways for bringing these software products to market, along with points to consider in developing short and long-term regulatory strategies. Our SaMD experts can also work to advise you on development of algorithm training and validation strategies and how clinical data expectations may be impacted by the selected regulatory pathway.

Areas of Focus

• Regulatory Assessments
• FDA Submissions
• QMS Development
• Post-Market Change Control Assessments

Medical Device Software Considerations

• Classification: Determine classification as software or device. Assess and develop regulatory pathway based on software claims and functionality. Prepare and lead regulatory submissions to FDA and OUS regulatory agencies.
• Software Training and Validation Requirements: Advise on training and validation activities of AI/ML-based algorithms.
• Cybersecurity Requirements: Advise and support development of cybersecurity risk management file.
• QMS-SDLC Interaction: Develop QMS integrating SDLC processes and assist with building SW Design History File.
• Post-Market Software Changes: Assess regulatory impact of post-market software changes, determine which require FDA review, and develop roadmap.

In Vitro Diagnostics (IVD)

In vitro diagnostics (IVD) products are medical devices that are intended for use in the diagnosis of disease or other medical conditions and assessing the current state of patient health. This unique subset of medical device includes reagents, instruments, software, and associated components that often work together as a system to achieve the design intent. ProPharma has expertise in the specific challenges that IVD manufacturers face in integrating the laboratory sciences with the engineering aspects of physical devices and instrumentation. We understand the entire IVD product lifecycle and can guide our clients through design and commercialization, manufacturing, and post market surveillance and reporting.

Drug-Device Combination Products

Navigate Complex Regulatory Pathways with Confidence

Combination products that integrate drugs, biologics, and medical devices present unique development and regulatory challenges—especially when expanding into global markets. ProPharma offers expert regulatory consulting to help you successfully develop and register drug-device combination products in the United States, European Union, and United Kingdom.

From early development and regulatory planning to submission and postmarket compliance, ProPharma offers tailored consulting services that account for the complexity of combination products across jurisdictions. Our global team of regulatory experts, including former FDA and MHRA officials, ensures that you’re prepared for every step.

From early development and regulatory planning to submission and postmarket compliance, ProPharma offers tailored consulting services that account for the complexity of combination products across jurisdictions. Our global team of regulatory experts, including former FDA and MHRA officials, ensures that you’re prepared for every step.

FDA Regulatory Strategy for Combination Products

In the US, combination products are regulated by the FDA's Office of Combination Products (OCP), which assigns primary jurisdiction to CDER, CBER, or CDRH based on the product's primary mode of action (PMOA).

Our team of experts guide you through:

• Pre-Request for Designation (Pre-RFD) and RFD submission strategies
• Primary jurisdiction determination
• IND, NDA, BLA, or 510(k)/PMA pathways based on product type
• Human Factors and usability study planning
• cGMP expectations across drug and device components
• Postmarket safety reporting requirements (21 CFR Part 4)

We help streamline your FDA interactions and ensure that all product components meet the applicable regulatory and quality standards.

EU Regulatory Compliance Under MDR and EU Pharma Law

Combination products in the EU may fall under the Medical Device Regulation (EU) 2017/745 (MDR) or Directive 2001/83/EC for medicinal products, depending on their primary function. We support:

• Determination of product classification and regulatory pathway
• CE marking under MDR for device-led combinations
• Consultation procedures with notified bodies and EMA for drug-device integrations
• Preparation of the device-specific annexes (e.g., Annex I and Annex III of MDR)
• Clinical evaluation, performance data, and safety justifications

Our integrated approach ensures that your combination product meets both medicinal product and medical device requirements in the EU.

UK Regulatory Strategy for Post-Brexit Compliance

Post-Brexit, the UK has adopted its own approach to regulating combination products via the MHRA. Our consultants offer expert guidance on:

• UKCA marking for device components
• National licensing routes for medicine-led products
• MHRA consultations for borderline or combination classifications
• Alignment with UK-specific pharmacovigilance and vigilance systems
• Planning for future regulatory divergence from the EU

We help Sponsors stay compliant with evolving UK regulations while maintaining efficiency in product development and market access.

Clinical Evaluation Reports (CERs) / Clinical Evaluation Plans (CEPs)

With local, regional, and global capabilities, ProPharma's team of experienced MedTech professionals support clients of all sizes to deliver CERs that meet and exceed regulatory standards.

We deliver results through an Advise | Build | Operate model to ensure data quality, reliability, regulatory compliance, and industry-leading language and writing expertise.

Clinical Evaluation Reports

• Clinical Evaluation Plan: Systematic approach & strategy, including a roadmap for conducting evaluations from development to post-market surveillance.
• Literature Search & Review: Identify & review relevant data obtained through literature searching to address safety, performance, side effects & risk-benefit analysis questions.
• Analysis/Appraisal of Clinical Data: Systematically analyze, interpret, and synthesize data. Plan and document the assessment for suitability, scientific validity, and contribution to the overall dataset.
• Post-Market Clinical Follow-Up (PMCF): Identify residual risks & gather long-term clinical performance data for better understanding.
• Clinical Study Execution: Design, plan, and execute experiments for interventional studies, surveys, registries & observational research.
• Demonstration of Equivalence: Identify & demonstrate the equivalence of an alternative device when appropriate for technical, biological & clinical evaluation.

Quality Systems & Regulatory Compliance

Based in the US & EU, ProPharma's industry-leading MedTech subject matter experts support clients with FDA 483s, Warning Letters, Recalls, Competent Authority, and NB Non-Conformances.

ProPharma's Quality Systems specialists help design and prepare Quality Management Systems (QMS) and SOPs compliant with FDA, MDR and international regulations, support clients through FDA/ISO and Notified Body audits as well as assistance in resolution of compliance issues such as 483 observations and Warning Letters. Our specialists also provide guidance for MDSAP certification.