What CRO Group does

CRO Group, Inc. (founded 1996, headquartered in Melrose, Massachusetts) is a privately held regulatory and quality consulting firm serving medical device, in-vitro diagnostic (IVD), over-the-counter (OTC), digital health, Software as a Medical Device (SaMD), and wearable product companies worldwide. The firm operates from three U.S. locations — Melrose (HQ), Boston, and Silicon Valley — and states worldwide service coverage spanning North America, Europe, Asia, Latin America, and Oceania. It is registered with the FDA as a U.S. Agent.

The company delivers six core consulting service lines: Auditing (internal audits, supplier audits, mock FDA inspections, MDSAP pre-audits), Training (custom programs covering EU MDR/IVDR, ISO 13485:2016, ISO 14971, IEC 62304 integrating Agile/SCRUM, MDSAP, and FDA QSR/Design Controls), Clearances & Approvals (510(k), PMA, 513(g), DeNovo, CE Marking technical files), Certifications (ISO 13485:2016, MDSAP, MDR/IVDR, FDA QMSR transition), Cybersecurity Services (FDA premarket and MDCG 2019-16 assessments aligned with NIST CSF), and Design Assurance & Risk Management (IEC 62304 SDLC, ISO 14971 risk management, IEC 62366 usability engineering, and clinical studies). It also maintains three specialized market practices: mHealth, OTC Aesthetic and SaMD/Wearable products, and Safety Critical Systems. The firm's proprietary "Swim Lane Development Process" integrates QMS Design Controls, SDLC, and Risk Management under a single Agile/SCRUM-aligned methodology.

The business model is project-based professional services with quote-based pricing and multi-year engagements, supplemented by an annual subscription offering seminar content and FDA Warning Letter previews. The firm employs 11-50 personnel, with senior consultants carrying 25+ years of experience and accredited Notified Body/MDSAP Lead Auditor credentials. Customer segments are horizontally diversified across the medical device value chain, with stated client sizes ranging from two-person startups to multi-division enterprises; the company notes that most clients are smaller in size. No external funding, M&A activity, or awards are disclosed.

Name

CRO Group

Legal name

The CRO Group, Inc.

Website

https://crogroup.com

Company type

Private

Founded year

1996

Operating status

Operating

Headcount range

11–50 employees

Short description

CRO Group is a privately held medical device regulatory and quality consulting firm founded in 1996, serving medical device, IVD, SaMD, and wearable product companies worldwide with FDA approvals, CE Marking, ISO 13485, MDR/IVDR, IEC 62304, and cybersecurity services from offices in Melrose, Boston, and Silicon Valley.

Ownership category

akta.pro rank

Headquarters

HQ city

Melrose

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory & Quality Consulting Services: Professional consulting services for medical device regulatory compliance, quality management systems, and product development. Revenue is generated through project-based consulting engagements, audits, training programs, and ongoing advisory services. The company offers services including internal audits, supplier audits, mock FDA inspections, MDSAP pre-audits, QSR readiness audits, and design controls support for SaMD product companies.
2. Training Programs: Custom training programs for regulated industries covering EU MDR/IVDR, ISO 13485:2016, ISO 14971, IEC 62304 (integrating Agile/SCRUM development), MDSAP, and FDA QSR including Design Controls. Training is delivered on-site, online interactive, or via slide decks in English and Mandarin.
3. Clearances & Approvals Services: Preparation and submission support for 510(k) Premarket Notifications, PMA Premarket Approval Applications, 513(g) determinations, DeNovo petitions, CE Marking technical files, design dossiers, and international registrations.
4. Clinical Studies & Performance Evaluations: Clinical study design and implementation, label comprehension studies, usability engineering per IEC 62366, safety and efficacy clinicals, clinical evaluations per MEDDEV 2.7.1 Rev 4, MDR clinical requirements, and IVDR performance evaluation requirements.
5. Annual Resources Subscription: Annual subscription access to seminars and FDA Warning Letter previews covering inspection issues, MDSAP, MDR/IVDR, and other regulatory topics.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

CRO Group provides regulatory, quality, and clinical consulting services for medical device, in-vitro diagnostic (IVD), over-the-counter (OTC), digital health, Software as a Medical Device (SaMD), and wearable product companies. The firm delivers auditing, training, FDA clearances/approvals (510(k), PMA, DeNovo), CE Marking, ISO 13485/MDSAP certification, cybersecurity assessments, design assurance, and clinical study services to help clients achieve regulatory compliance and product approvals worldwide.

Product overview

CRO Group is a consulting organization providing specialized regulatory, quality, and development services for medical device, In-Vitro Diagnostic, OTC, Digital Health, Software as a Medical Device (SaMD), and Wearable product companies. Their service portfolio is organized into six core consulting areas: Auditing Services (internal audits, mock FDA inspections, MDSAP pre-audits), Training Services (custom programs for FDA QSR, ISO 13485, IEC 62304), Clearances & Approvals Services (510(k), PMA, CE Marking, technical files), Certifications Services (ISO 13485, MDSAP, MDR/IVDR), Cybersecurity Services (FDA premarket/postmarket guidance, MDCG compliance), and Design Assurance Services (IEC 62304 SDLC, risk management, clinical studies). They also serve three specialized markets: mHealth Apps, OTC Aesthetic/Wearable products, and Safety Critical Systems. CRO Group acts as FDA U.S. Agent and provides worldwide services with expertise spanning FDA approvals, CE Marking, clinical studies, ISO 13485:2016, MDSAP, ISO 14971, IEC 62304, and related regulatory requirements.

Differentiator

Problem solved

Functional benefit

Products and services

• Auditing Services Internal audits, supplier audits, mock FDA inspections, and MDR/IVDR Notified Body audits for medical device and IVD companies. Includes due diligence audits for pre-acquisition and VC/Angel review of potential investments, ISO 13485:2016 and MDSAP pre-audits, and QSR with Design Controls readiness audits for SaMD companies prior to FDA device listing.
• Training Services Custom training programs covering EU MDR/IVDR, ISO 13485:2016, ISO 14971, IEC 62304 (integrating Agile/SCRUM development), MDSAP, and FDA QSR including Design Controls. Programs range from short seminars on specific requirements to day-long courses, applicable to SaMD and medical device products with software.
• Clearances and Approvals Services Preparation and submission support for FDA 510(k) Premarket Notifications, PMA Premarket Approval Applications, 513(g) determinations, DeNovo petitions, CE Marking technical files and design dossiers, and international registrations for global market access.
• Certifications Services ISO 13485:2016 certification preparation, MDSAP certification support, EU MDR/IVDR compliance, and FDA QMSR (Quality Management System Regulation) transition planning and readiness support for medical device manufacturers.
• Cybersecurity Services Documented cybersecurity assessments based on FDA Premarket Guidance following NIST Cybersecurity Framework, MDCG 2019-16 compliance, SDLC cybersecurity integration, and post-market surveillance support for connected medical devices and SaMD products.
• Design Assurance and Risk Management Services IEC 62304 SDLC consulting using the Swim Lane process merging QSR, ISO 13485:2016 Design Controls, ISO 14971 Risk Management, and Agile/SCRUM. Includes risk management, usability engineering per IEC 62366, verification and validation, and design documentation support for FDA and EU regulatory submissions.
• Clinical Studies Services Clinical study design and implementation including label comprehension studies, usability engineering per IEC 62366, safety and efficacy clinicals, clinical evaluations per MEDDEV 2.7.1 Rev 4, MDR clinical requirements support, and IVDR performance evaluation requirements.
• mHealth Market Services Consulting for mobile health applications, including determining 510(k) or Notified Body review requirements, de Novo or PMA pathways, and MDR/IVDR classification for mHealth, SaMD, and AI-enabled diagnostic applications.
• OTC Aesthetic Premarket and Manufacturing Readiness 510(k) preparation and clinical study design for OTC aesthetic products including hair regrowth, hair removal, and fat reduction devices, plus manufacturing readiness support for GMPs/QSR compliance.
• Safety Critical Systems Services FDA and EU submission support for safety critical medical systems including diagnostic imaging (PET scanners), cell washing systems, surgical robotics, and rare allele diagnostic assays. Covers risk management, functional safety, usability, labeling validation, system and software V&V, and design documentation.
• MDR/IVDR Transition Services Gap analysis for CE Marked products and Quality Management System, quality plan development, technical documentation preparation, and Notified Body transition coordination for EU MDR and IVDR compliance.
• Seminar Resources Subscription Annual subscription providing access to seminar content and FDA Warning Letter previews covering MDSAP, EU MDR/IVDR, IEC 62304 for SaMD, Risk Management ISO 14971, ISO 13485:2016, and FDA Warning Letters.

Quantifiable outcome

• 510(k) cleared in as little as 6 months for one hair removal device when involved early in development

Segments6 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators3 records

Recent moves6 records

Expansion highlights7 records

Direct peers

• Kymanox: Kymanox is a direct peer offering regulatory, quality, and engineering consulting for medical devices, combination products, and biologics — closely aligned with CRO Group's design assurance and regulatory submission services.
• Validant: Validant is a specialized regulatory consulting firm serving pharmaceutical and medical device companies with FDA, EU MDR/IVDR, and quality system services — directly comparable in niche focus and service portfolio to CRO Group.
• RQM+: RQM+ is a direct competitor providing medical device and IVD regulatory, quality, and clinical consulting services globally, with overlapping service lines in 510(k), CE Mark, ISO 13485, MDSAP, and SaMD regulatory strategy.

Broad incumbents

• TÜV SÜD: TÜV SÜD is a large global testing, inspection, and certification organization with active medical device regulatory and quality system services — competes with CRO Group for ISO 13485, MDR/IVDR, and CE Marking engagements.
• Intertek: Intertek provides medical device testing, certification, and regulatory advisory services globally. It overlaps with CRO Group on quality system audits, EMC/electrical safety testing, and CE Mark technical documentation.
• BSI Group: BSI is a major global certification and standards body that also provides ISO 13485, MDSAP, and CE Mark Notified Body services. It competes with CRO Group's certification preparation services while offering bundled testing and certification.
• IQVIA: IQVIA is a global CRO and regulatory services platform with significant medical device and SaMD regulatory consulting capabilities. As a much larger player, it competes with CRO Group on enterprise-scale regulatory submissions and clinical studies.
• Emergo by UL: Emergo by UL is a larger, established regulatory consultancy (now part of UL Solutions) covering FDA, CE Mark, MDSAP, and global medical device registrations — overlapping with CRO Group's clearance and approval services but at significantly greater scale.
• NAMSA: NAMSA is a global medical device-focused CRO providing regulatory, quality, and clinical research services. It overlaps with CRO Group's clinical studies, regulatory strategy, and quality system offerings, particularly for safety-critical and combination products.

Emerging players

• MedDev Compliance: MedDev Compliance is a smaller emerging regulatory consulting firm focused on FDA, CE Mark, and ISO 13485 services for medical device companies — a niche competitor comparable in size and specialization to CRO Group.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/crogroup
• Facebookfacebook.com/crogroup

Revenue estimate

Valuation estimate

Number of profiles

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 CRO Group