What MEDIcept does

MEDIcept is a privately held professional services firm founded in 1996 that provides regulatory, quality, clinical, and compliance consulting exclusively to the medical device and in-vitro diagnostics (IVD) industry. The firm is organized around six interconnected service pillars: Regulatory Affairs (FDA and global submission pathways including 510(k), De Novo, PMA, EU MDR/IVDR), Quality Assurance and Quality Management Systems, Clinical Services (full-service CRO with trial design, monitoring, biostatistics, and medical writing), Engineering (software compliance, cybersecurity, human factors), Reimbursement Strategy, and Healthcare Compliance Consulting. Delivery is positioned as senior-led and hands-on, supported by 11–50 employees operating from a headquarters in Ashland, Massachusetts and a regional office in Copenhagen, Denmark.

The firm generates revenue through quote-based, project-driven professional services engagements, with billing structured around multi-year contracts tailored to client scope. MEDIcept has expanded its capabilities and footprint primarily through inorganic moves: a 2019 merger with Reilly & Associates, the 2020 acquisition of Quality Systems in Motion (QSIM), the 2021 acquisition of ACMP Clinical and Regulatory Consulting (extending into full CRO services), and a 2024 strategic collaboration with Pure Global for international market access. The firm also maintains a technology integration partnership with Arena Solutions for QMS tooling.

MEDIcept serves a horizontal mix of customers including funded startups and innovation ecosystems, Class II/III medical device manufacturers, global manufacturers with multi-region compliance needs, digital health companies, contract manufacturers and design firms, private equity and venture capital portfolios, and academic/nonprofit/government programs. Leadership includes CEO Jason Gromek (appointed March 2025), Managing Director and VP Kim Trautman (former FDA Associate Director of International Affairs, appointed February 2022), and VP of Compliance and Reimbursement Stephanie Patterson. The firm has no public listing, no disclosed funding rounds, and no parent company, with ownership appearing to be management-controlled.

Name

MEDIcept

Legal name

Medicept

Website

https://medicept.com

Company type

Private

Founded year

1996

Operating status

Operating

Headcount range

11–50 employees

Short description

MEDIcept is a privately held, 11–50 employee regulatory, quality, clinical, and compliance consulting firm founded in 1996, serving medical device and IVD companies from funded startups through global manufacturers across US and international markets.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Management Consulting Services (54161), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Management Consulting Services (8742), Services-Health Services (8000)

akta.pro primary industry

Clinical Operations & Monitoring FSP (CRA/CTM/Start-up) (HLAGAOAA)

akta.pro secondary industries

Data Management, Biostatistics & Statistical Programming FSP (HLAGAOAB), Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

Keywords

• Medical device consulting
• Regulatory affairs services
• Quality management consulting
• Clinical research services
• FDA compliance consulting

Headquarters

HQ city

Boston

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D

Revenue model

1. Regulatory and Quality Consulting Services: MEDIcept generates revenue through professional consulting services including regulatory affairs, quality management systems, clinical operations, compliance consulting, reimbursement strategy, and engineering services. The firm provides senior-led, hands-on support to medical device and IVD companies throughout the product lifecycle from first idea to post-market success.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

MEDIcept is a professional consulting firm providing regulatory affairs, quality management systems, clinical research (CRO), engineering, reimbursement strategy, and healthcare compliance consulting services exclusively for medical device and in-vitro diagnostics (IVD) companies. The firm delivers senior-led, hands-on consulting engagements supporting clients from first idea through post-market success, including FDA and EU MDR/IVDR submissions, quality system development, clinical trial management, and emergency regulatory response.

Product overview

MEDIcept is a full-service regulatory, quality, and clinical consulting firm focused on medical devices and in-vitro diagnostics (IVD). The company operates as a unified consulting practice organized into six interconnected service pillars: Clinical Services (full-service CRO with trial management and medical writing), Quality Assurance (QMS development, audits, remediation, cybersecurity), Regulatory Affairs (FDA and global submissions), Engineering (software compliance and human factors), Reimbursement Strategy, and Healthcare Compliance Consulting. These services are delivered through senior-led teams supporting clients from funded startups through global manufacturers. The company also maintains strategic partnerships with Pure Global for global market access and Arena Solutions for QMS integration, extending its reach without requiring customers to purchase separate products or modules.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Services Full-service CRO offering clinical operations support including protocol development, site start-up, IRB communication, trial monitoring, biostatistics, data management, safety monitoring, medical writing, and clinical audits across feasibility, pivotal, and post-market studies for medical device and IVD companies.
• Quality Assurance (QA) Quality assurance consulting covering quality system development, quality and compliance audits, QMS remediation, post-market surveillance reports, medical device software compliance, cybersecurity, and usability engineering for medical device and IVD manufacturers.
• Regulatory Affairs Regulatory strategy and submission services for FDA and global markets including Q-Submissions, 510(k), De Novo, PMA, Breakthrough Devices Designation, EU MDR/IVDR technical documentation, and CERs/PERs for medical device and IVD companies.
• Engineering Engineering services including medical device software compliance, cybersecurity risk management, and human factors engineering for connected devices and digital health products.
• Reimbursement Services Medical device reimbursement strategy consulting including health economic analysis, reimbursement strategy roadmap, landscape assessment, CPT/HCPCS coding applications, coverage strategies, and operational reimbursement function design for medical device companies.
• Healthcare Compliance Consulting Compliance program development including compliance officer support, fractional compliance officer services, fraud waste and abuse prevention, HIPAA privacy compliance, compliance training, gap analysis, and ongoing monitoring for healthcare organizations.
• Safety Risk Management Safety risk management consulting covering identification and assessment of device hazards, risk estimation, mitigation strategies, prevention and early detection, and continuous monitoring aligned with FDA and ISO standards for medical devices.
• Quality Management Systems (QMS) Quality management system design and optimization covering people, processes, and technology aspects to enable compliance, efficiency, and quality-driven culture for medical device manufacturers.
• Regulatory Submissions for Medical Devices

Segments7 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Six partnerships are on record, tiered core and major.

• Pure GlobalcoreStrategic or Co-development Partner · 2 May 2024MEDIcept and Pure Global announced a strategic collaboration on May 2, 2024, to streamline medical device and IVD market access. The partnership combines Pure Global's global market access services with MEDIcept's expertise in US and EU regulatory, quality, and clinical services. This collaboration enables clients to access comprehensive support for both US and international market entry.
• ACMP Clinical and Regulatory Consulting, LLCmajorStrategic or Co-development Partner · 4 January 2021MEDIcept Inc. acquired ACMP, a US-based privately held Clinical Research Organization (CRO) that provides clinical research services. The acquisition expanded MEDIcept's service offerings to include full clinical operations support including protocol development, site start-up, IRB communication, trial monitoring, biostatistics, data management, and medical writing.
• Arena SolutionscoreTechnology or Integration · 7 December 2020MEDIcept Inc. and Arena Solutions announced a partnership to improve compliance for medical device manufacturers. The partnership combines Arena's leading QMS (Quality Management System) solutions with MEDIcept's quality management, regulatory, and engineering services to provide comprehensive compliance solutions.
• Quality Systems in Motion, Inc. (QSIM)majorStrategic or Co-development Partner · 6 January 2020Quality Systems in Motion, Inc. (QSIM), a US-based privately held consulting firm specializing in medical device quality and regulatory consulting, became part of MEDIcept Inc. This acquisition strengthened MEDIcept's capabilities in quality system development and regulatory consulting services.
• ACMP ConsultingmajorStrategic or Co-development Partner · 14 November 2019MEDIcept Inc. and ACMP Consulting entered into an agreement to provide Clinical Research Organization (CRO) services for early phase, pre-, and post-market studies. The collaboration offered medical device companies full clinical operations support including protocol development, site start-up activities, IRB communication, trial monitoring, biostatistics, data management, and medical writing.
• Reilly & AssociatesmajorStrategic or Co-development Partner · 14 March 2019MEDIcept Inc. and Reilly & Associates, a US-based privately held consulting firm specializing in medical device/biotechnology, announced a merger. Both companies shared a common goal to positively impact medical device compliance and safety. The merger promoted the shared strategic goal of becoming a worldwide, leading quality and regulatory value-added service firm.

Scale indicators3 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• MethodSense: MethodSense is a medical device regulatory and quality consulting firm offering FDA submission, QMS, clinical, and compliance services. It closely mirrors MEDIcept's boutique MedDev consulting model with similar service pillars and target clients (Class II/III manufacturers).
• Regulatory Compliance Associates (RCA): RCA provides regulatory, quality, and compliance consulting exclusively for the medical device and life sciences industry. It competes directly with MEDIcept on FDA 483 remediation, QMS development, and regulatory submissions for MedDev and IVD clients.
• Pure Global: Pure Global is a regulatory and market access consulting firm specializing in medical devices and IVDs across global markets. It is a direct strategic partner of MEDIcept but also a competitor for international regulatory submission work, particularly EU and emerging-market pathways.
• Proxima Clinical Research: Proxima is a medical device CRO offering regulatory strategy, clinical trial management, biostatistics, and medical writing. It overlaps directly with MEDIcept's clinical services pillar and shares a similar boutique consulting model focused on MedDev clients.

Broad incumbents

• NAMSA: NAMSA is the largest medical device-focused CRO offering regulatory, quality, clinical, and testing services globally. It is comparable to MEDIcept as a direct competitor in MedDev regulatory and clinical consulting, but at significantly larger scale and broader geographic reach.
• Parexel: Parexel is a global CRO with a dedicated MedTech practice providing regulatory, clinical, and post-market services. Comparable to MEDIcept's clinical and regulatory offerings, but at global CRO scale with broader therapeutic-area coverage and biopharma cross-sell.
• Veranex: Veranex is a MedTech-focused consulting and contract services platform spanning regulatory, clinical, design, and engineering. It is comparable to MEDIcept as a full-lifecycle medical device services provider but operates with substantially larger scale and integrated product development capabilities.
• IQVIA: IQVIA is a global CRO and healthcare data platform offering clinical, regulatory, and quality services including for medical devices. It is a much larger incumbent whose medical device practice competes with MEDIcept on multi-region regulatory and clinical engagements.

Emerging players

• Rimsys: Rimsys provides regulatory information management (RIM) software purpose-built for medical device companies. While MEDIcept offers regulatory consulting services, Rimsys represents the software-enabled alternative that automates parts of the workflow MEDIcept currently delivers manually.
• Greenlight Guru: Greenlight Guru offers a QMS platform specifically designed for medical device companies. It competes with MEDIcept's quality systems consulting practice by enabling in-house compliance teams to self-serve, potentially reducing demand for external consulting hours.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/medicept

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about MEDIcept