Global MedTech Solutions
Our experts understand what it takes to get these products to market and help design efficient and compliant trials as needed to help meet your goals.

RCO
Global MedTech Solutions
Our experts understand what it takes to get these products to market and help design efficient and compliant trials as needed to help meet your goals.

RCO

MedTech Services
From concept development through Food and Drug Administration (FDA), international regulatory submissions, and European Union (EU), our team of specialists is highly qualified to assist you in all aspects of medical device and diagnostic regulation throughout the product lifecycle. If you are in process of developing an regulated product, our experienced team of specialists can help you achieve successful regulatory outcomes, globally. We work in the most expeditious way possible to help you realize the value of those outcomes sooner.
All MedTech Services
The regulatory path for medical devices and diagnostics is different from drug development, which is why we have a dedicated team of experts who focus solely on supporting our device and diagnostics clients.
MedTech Product Development & CRO Services
Clinical Trials
ProPharma MedTech offers a full range of CRO services for first-in-human and early feasibility studies, nonsignificant risk studies, multicenter pivotal trials to support regulatory approvals, usability and human factors studies, and post-market studies to support reimbursement determinations, marketing objectives, or as required to maintain CE marking or as a condition of regulatory approval. We support our clients through FDA audits of investigational sites and have successfully passed multiple FDA audits of studies we have managed.
Global Medtech CRO Services:
- Protocol/ Medical Writing
- Clinical Trial Site Selection & Qualification
- Clinical Trial Budgets & Negotiations
- Clinical Study Start-up & Patient Recruitment
- Clinical Trial Monitoring & Site Management
- Clinical Data Management & Biostatistics
- Clinical Trial Vendor management
- Clinical Trial Management Systems
- Clinical Safety Management (DSMB/CEC)
- Clinical & Regulatory Audit Preparation and Support
- Post Market Studies
- Human Factor/Usability Study Management
- Clinical Quality Assurance
Our clinical experts routinely work with ProPharma’s regulatory experts to provide strategy and support for IDE’s, interact with FDA during the review process, and arrange and participate in pre-submission meetings. Having a long history of receiving FDA Investigational Device Exemption (IDE) approvals and have served as the Contract Research Organization (CRO) for countless studies to support 510(k), de novo and PMA applications, as well as CE marking.
Clinical Study Global Expertise:
- Enhanced bone void filler for multiple applications
- Type II diabetes management device
- Lumbar and cervical disc replacement devices
- HIFU system to treat prostate cancer
- Cardiac ablation for atrial fibrillation
- UV blood irradiation for HIV
- Noninvasive vagus nerve stimulator (multiple indications)
- Total Hip Replacement System
- MIS ablation procedure for low back pain
- Wearable spine rehabilitation device
- Shockwave treatment for non-unions, sports injuries, wound healing in OA
- HPV testing in cervical cancer
- In vitro human embryo development
- Electrical bone growth stimulator
- Diagnostic product for detection of skin melanoma
- Hydrogel nucleus replacement device
- Wearable software device for Atrial Fib
- Cell harvesting device for knee OA indications
Digital Health
Software Functions and SaMD
ProPharma's industry-leading MedTech professionals provide guidance on software-related questions to support clients of all sies. 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.

IVD Areas of Focus:
- Molecular Diagnostics
- Companion Diagnostics
- Point of Care Testing (POCT)
- Immunoassays
- Naval Assays
- Near Patient/Self Testing
In addition to a full suite of quality solutions, we support our clients with regulatory strategy and submission capabilities for the US and international markets. We also provide gap assessments and preparation services for transition from EU IVDD to IVDR.
Medical Device 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 consulting capabilities across the globe, including an all-inclusive medical device consulting service offering. 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, clinical study execution and quality management system support for more than 23 years.
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.
As the world's largest RCO (Research Consulting Organization), we deliver results through an Advise | Build | Operate model to ensure data quality, reliability, regulatory compliance, and industry-leading language and writing expertise.
665
CERs Delivered
10+
Years Delivering CERs
40%+
Leading Clients
30%+
Start-Up | Early Stage
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.
Global Medical Device Regulatory Support
ProPharma Group is an established partner with a large segment of the med tech industry ranging from small entrepreneurial start-ups to multinational device manufacturers. The company is a trusted advisor in providing clients comprehensive strategic solutions for complex regulatory challenges that are commonly associated with getting the most ground-breaking technologies from concept to market. With a corporate culture that fosters innovative thinking, we take care to understand each client's US, EU and global marketing objectives; this provides assurance that the regulatory and clinical strategy complement client plans for global regulatory agency review and international commercialization.
It is essential to have a strategic and well thought-out plan when preparing to approach regulatory bodies seeking approval of your medical device. Each interaction with an agency should be carefully and tactically organized to maximize the information gained at each step of the development process. A sound regulatory strategy provides an actionable roadmap that you need.
Each company and product are unique. Accordingly, the journey taken to obtain FDA approval for your medical device will also be unique. We understand this and develop customized regulatory strategies for every company and every product, focusing on each client’s individual needs.
Regulatory affairs services range from support at earlier stages of product development for pre-submission meetings to formal preparation of 510(k)s and de novo petitions, IDEs, HDEs, and PMAs. International specialists have extensive experience in the selection of Notified Bodies, preparation of Technical Files and Dossiers for CE marking under EU MDR and global regulatory submissions.
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.
50+
FDA 483 Resolutions
10+
Years Remediation Experience
40+
Competent Authority & NB Remediations
MedTech Experts
Global Medtech Experts. Deep Domain Expertise.

Ron Freeze
Global Head Of Medical Technology
Tina Hudson
Director, Diagnostic and Combination Products
Joyce Ludwig
Quality Project Manager

Kristin Robinson
Senior Project Manager - Clinical Research Solutions
Jennifer Daudelin
Senior Project Manager - Clinical Research Solutions
MedTech Resources

Pathways to Market for Medical Devices in the U.S.
Medical devices are regulated by the Center for Devices and Radiological Health (CDRH) at the FDA. Which approval pathway is appropriate for your product? You have developed a medical device and are...

Navigating QMS Requirements from a Medical Device Perspective
Having a different number of pharmaceutical classified products in your portfolio provides a challenge in EU. As distribution and sales of MD products are under MDR, while pharmaceuticals are under...
News & Insights

November 27, 2023
Key Steps to Creating a Successful Market Access Strategy
Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...

November 20, 2023
The Hidden Costs of Project Communication Gaps
Ineffective communication may be a key factor contributing to the challenges in your projects. Communication is a vital aspect of our daily lives, and the success of a project is closely linked to...

November 27, 2023
EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

November 16, 2023
ProPharma Launches an Integrated MedTech Organization Providing End-to-End Solutions for Innovators
Raleigh, NC, November 16, 2023: ProPharma Group, the world’s largest Research Consulting Organization (RCO) and the leading global provider of regulatory, clinical and quality compliance services for...

October 11, 2023
ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

May 3, 2022
ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook
ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric Approach to Clinical Research Solutions ProPharma Group is honored to be named Top 10 CRO 2022 by Pharma Tech Outlook...

April 21, 2022
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded "Best Pharmaceutical Regulatory & Compliance...

June 10, 2022
The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

August 31, 2022
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...
News & Insights

November 27, 2023
EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

November 16, 2023
ProPharma Launches an Integrated MedTech Organization Providing End-to-End Solutions for Innovators
Raleigh, NC, November 16, 2023: ProPharma Group, the world’s largest Research Consulting Organization (RCO) and the leading global provider of regulatory, clinical and quality compliance services for...

October 11, 2023
ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

April 21, 2022
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded "Best Pharmaceutical Regulatory & Compliance...

Nov 27, 2023 7:00:00 AM
Key Steps to Creating a Successful Market Access Strategy
Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...

Nov 20, 2023 7:00:00 AM
The Hidden Costs of Project Communication Gaps
Ineffective communication may be a key factor contributing to the challenges in your projects. Communication is a vital aspect of our daily lives, and the success of a project is closely linked to...

October 14, 2021
Accelerate European Market Access with Compliant and Comprehensive MAA Submission
Preparedness for Marketing Authorization Application (MAA) approval ensures an efficient application process and follow-up. Placing a medicinal product in the European market requires a license for...

March 18, 2022
Outsourcing QA - Reduce Time and Expense While Meeting Critical Requirements
There is a tendency for VPCs to rely solely on the QC/QA units within their outsourced CMO to perform quality functions. However, the sponsor organization has the ultimate responsibility for product...

October 14, 2021
Dedicated Project Manager Directs Regulatory Activities Throughout European Economic Area
Learn how a single point of contact oversaw local regulatory affairs activities across all 31 countries of the EEA. You’re developing a drug, biologic, or medical device product. There are a lot of...

September 1, 2022
Webinar: AI-Powered MI Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability
Today's Medical Information (MI) industry is being driven by evolving customer behavior requiring a more rapid, omnichannel, and digital response to customer needs. The expectation for higher...

October 14, 2021
Ensure Successful Acquisitions with Complete and Accurate Regulatory Due Diligence
Ensure you have as much information as possible to thoroughly evaluate the potential investment when acquiring a company or product. When considering the acquisition of a new company or product, it...

October 14, 2021
Ensure Successful Batch Release, Regulatory Compliance with Experienced Qualified Persons
Streamlining a CMO’s manufacturing process helped ensure GMP compliance for EU batch release and USA inspection readiness. A contract manufacturing organization (CMO) needs to have a reliable quality...

October 4, 2021
How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach
A global biopharmaceutical client with multiple sites operating under a Warning Letter from the U.S. Food and Drug Administration (FDA) needed significant cross-functional support to meet remediation...

October 14, 2021
Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline
Risk evaluation of products containing chemically synthesized APIs must be done to assess adherence to nitrosamine regulations. Marketing Authorization Holders (MAHs) must perform a risk evaluation...

October 4, 2021
Increased Visibility for Senior Management with Custom PMO Design, Implementation
Time. Regardless of company size and the number of products in your portfolio, time is one thing we could all use more of. However, the more projects you have in your portfolio, the more stretched...

October 14, 2021
Initiating Enrollment for Accelerated COVID-19 Treatment Studies in 6 Days
In May 2020, as the FDA released new guidelines to accelerate the development of novel COVID-19 therapeutics and vaccines, our Clinical Services experts were asked to provide independent Data Safety...

October 14, 2021
MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction
A routine safety letter to healthcare professionals (HCPs) was misinterpreted by recipients, causing a “recall-like” crisis event for a multinational pharmaceutical client. When a routine safety...

December 2, 2023
Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life
In the competitive and fast-moving Cell and Gene Therapy (CGT) field, developers face a range of scientific, technical, and regulatory challenges that can quickly become overwhelming and costly. In...

May 19, 2022
Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective
As businesses face the shared global challenges of adapting to new operating models triggered by the recent pandemic, regulated drug and device sponsors, marketing authorization holders, and...

March 25, 2022
Insider Talks - To Decentralize or Not to Decentralize … That is the Question
Having a decentralized approach is critical to ensuring continuity in the face of disaster, and important in meeting your overall enrollment goals while increasing patient diversity. Join us for our...

October 14, 2021
Secure Timely Product Launch by Ensuring GDP Compliance Across Europe
Our client was in the phase of submitting a Marketing Authorization Application (MAA) in the EU and needed to apply for a Wholesale Distribution Authorization (WDA). After application and approval of...

October 14, 2021
Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors
Managing and sharing large amounts of clinical data provided by a team of ten plus vendors is extremely challenging and requires meticulous attention to detail and expert-level project management to...

October 14, 2021
Understanding Clinical Trial Requirements for Medical Device Label Extensions
After you have developed an FDA-regulated product and obtained marketing approval, you may think your job is done. However, after all the time, effort, money, and so much more that goes into product...

October 17, 2021
Outsourcing of Medical Information Content Creation: Experience of 100 Clients
The time and effort required to write, review, edit, approve, maintain, distribute, and update Medical Information (MI) documents while retaining an auditable record of the search strategy is a great...

October 4, 2021
Outsourcing Medical Information Services: When to Consider a Dedicated Resource
Outsourcing Medical Information (MI) services can be an effective solution for ensuring the provision of MI services to HCPs and consumers globally. The most cost-effective model for the provision of...

May 3, 2023
Improve Quality & Consistency by Leveraging AI for Trial Master File Classification
Improve Quality and Consistency by Leveraging AI for Trial Master File Classification The whitepaper "Improve Quality and Consistency by Leveraging AI for Trial Master File Classification" addresses...