What GemarMed srl does

GemarMed srl is a privately held Italian regulatory affairs and quality assurance consultancy headquartered in Medolla (Modena), Italy, founded in 2010 by Dr. Mario Gennari. The firm serves medical device, in vitro diagnostic (IVD), and pharmaceutical companies globally, with operating geographies covering Italy, the United States, China, and the United Kingdom. Its service portfolio spans the full product quality lifecycle, including CE Marking under MDR (EU 2017/745), IVDR compliance for in vitro diagnostics, FDA 510(k)/PMA/De Novo submission support, NMPA/CFDA approval assistance, ISO 13485 and 21 CFR Part 820 quality management system implementation, clinical evaluation and PMCF studies, sterilization validation (EO, gamma, e-beam, VHP, steam), software validation per IEC 62304 and GAMP 5, and statutory roles such as Person Responsible for Regulatory Compliance (PRRC) and UK Responsible Person (UKRP).

The company operates as a boutique professional-services firm with approximately 9 employees, eight of whom are named senior consultants and practice leaders covering complementary specialties such as design control, process validation, biological evaluation, combination products, GMP auditing, and FDA US Agent representation. Differentiation rests on the credentials of its team, which includes former Notified Body officials from TÜV SÜD Product Service and certified ISO 13485/QSR lead auditors, as well as longstanding relationships with various Notified Bodies across Europe. The firm has disclosed completion of more than 100 bespoke PMCF surveys for leading medical device manufacturers and support through hundreds of successful audits, though no customer logos or revenue figures are publicly disclosed.

GemarMed generates revenue through project-based and retainer consulting engagements acquired via direct sales, expert consultations, and industry event participation. Pricing is quote-based and not publicly disclosed. Marketing channels include a LinkedIn company page, an academy of RA/QA training workshops and conferences, and a content-rich website covering MDR/IVDR/FDA guidance. The firm holds no patents, has no software products or APIs, has completed no funding rounds, and operates without an external parent or institutional investor backing.

Name

GemarMed srl

Legal name

GEMARMED S.r.l.

Website

https://gemarmed.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

1–10 employees

Short description

GemarMed srl is an Italian regulatory affairs and quality assurance consultancy serving medical device, IVD, and pharmaceutical companies with CE Marking, FDA, NMPA, and QMS services, plus PRRC and UKRP statutory roles, across Europe, the US, China, and the UK.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH)

Keywords

• Medical device regulatory
• Quality management consulting
• CE marking compliance
• FDA approval services
• Sterilization validation

Headquarters

HQ city

Medolla

HQ country

Italy

HQ region

Europe

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 Consulting Services: GEMARMED provides regulatory affairs and quality assurance consulting services to medical device, IVD, and pharmaceutical companies. Services include CE marking preparation, FDA approval assistance, QMS implementation, clinical evaluation, sterilization validation, and audit preparation. Revenue is generated through professional service engagements, likely structured as project-based or retainer arrangements.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

GemarMed srl is a regulatory affairs and quality assurance consultancy serving medical device, in-vitro diagnostic (IVD), and pharmaceutical manufacturers. The firm guides clients through CE marking under the EU MDR/IVDR, FDA approval pathways (510(k), PMA, De Novo, EUA, Pre-Submission, IDE), and NMPA/CFDA approval in China. Services span the product lifecycle: design control and DHF preparation, QMS implementation per ISO 13485 and 21 CFR Part 820, clinical evaluation and PMCF survey design, sterilization validation across EO/gamma/E-beam/VHP/steam modalities, software validation per IEC 62304/GAMP 5, combination products compliance, audit and Notified Body inspection readiness, and PRRC/UKRP regulatory role fulfillment, delivered via project-based consulting and training workshops.

Product overview

GemarMed srl is a Regulatory Affairs and Quality Assurance consultancy firm founded in 2010, serving medical device, IVD, and pharmaceutical companies. Their service portfolio encompasses medical device certification (CE Marking, MDR, FDA, CFDA/NMPA), IVD certification under IVDR, medical device development consulting (DHF, usability engineering, project management), quality management system implementation (ISO 13485, FDA 21 CFR Part 820), combination products certification (EU MDR, FDA CFR Part 4), inspection preparation (internal/external audits, Notified Body audits), regulatory compliance roles (PRRC, UKRP), sterilization validation, and professional training. The company operates as a services-only consultancy with no software products, APIs, or AI-powered tools.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Device Certification Services Comprehensive regulatory consultancy covering CE Marking under EU MDR, MDR compliance, risk assessment, biological evaluation, process validation, software validation, clinical evaluation, FDA approval, and NMPA/CFDA approval for medical device manufacturers seeking market access in the EEA, United States, and China.
• IVD Medical Device Certification Services Regulatory assistance for In Vitro Diagnostics under the IVDR (EU 2017/746), including CE marking preparation, device classification, technical documentation, and transition support from IVDD to IVDR for IVD manufacturers.
• Medical Device Development Consulting Product development support including DHF (Design History File) consulting, project management, usability engineering file preparation, and design control services aligned with MDR and FDA requirements for medical device manufacturers.
• Quality Management System (QMS) Services QMS establishment and maintenance services including ISO 13485 certification support, EU MDR compliance, FDA 21 CFR Part 820 preparation, IEC 62304 consultancy, and clinical practices audits for medical device and IVD companies.
• Combination Products Certification Regulatory compliance services for drug-device combination products under EU MDR 2017/745 and FDA CFR Part 4, including GSPR compliance and GMP requirements for pharmaceutical companies developing combination products.
• Inspection Preparation Services Internal and external audit preparation, ISO 13485 audit support, 21 CFR Part 820 inspection readiness, and Notified Body audit preparation services for medical device and IVD companies facing regulatory inspections.
• Regulatory Compliance Services (PRRC, UKRP) Person Responsible for Regulatory Compliance (PRRC) and UK Responsible Person (UKRP) services to fulfill MDR requirements for medical device manufacturers needing EU and UK market access representation.
• Sterilization Validation Services Sterilization validation consulting covering ethylene oxide (EO), gamma irradiation, electron beam, vaporized hydrogen peroxide (VHP), and steam sterilization methods, including ISO 11135, ISO 11137, and ISO 17665 compliance for medical device manufacturers.
• Training Services Educational workshops and training programs covering regulatory requirements, quality assurance, PRRC certification, CE Marking, IVDR, and QA integration with development for medical device, IVD, and pharmaceutical professionals.

Quantifiable outcome

• Completed more than 100 bespoke PMCF surveys for leading medical device manufacturers
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators6 records

Recent moves6 records

Broad incumbents

• SGS: World's largest testing, inspection, and certification company offering medical device regulatory affairs, CE Marking, and quality system services; broad incumbent whose meddev practice overlaps directly with GemarMed's core offerings.
• ICON plc: Global CRO with a dedicated medical device and diagnostics regulatory services division offering clinical research, regulatory affairs, and quality consulting — comparable in regulatory scope though far larger and clinically focused.
• TÜV SÜD: Global Notified Body and certification giant providing CE Marking, ISO 13485, and medical device testing services; GemarMed's founders are former TÜV SÜD Product Service officials, making it both a key ecosystem relationship and a scaled competitor.
• NSF International: Global public health and safety organization offering medical device certification, regulatory consulting, and training services; comparable in training/workshop monetization and QMS offerings though at significantly greater scale.
• DEKRA: International testing, inspection, and certification organization with medical device certification and regulatory services; competes with GemarMed on CE Marking and ISO 13485 work but at enterprise scale with broader geographic reach.
• BSI Group: Major Notified Body and standards organization providing CE Marking, ISO 13485 certification, and regulatory services for medical devices — a large incumbent that GemarMed frequently routes clients to and competes against on standalone consulting work.

Direct peers

• Maetrics: Life sciences regulatory and quality compliance consultancy with strong EU MDR focus, providing quality systems, clinical evaluation, and compliance services to meddev manufacturers — highly comparable service portfolio and target client base.
• NAMSA: Medical device-focused contract research organization and regulatory consulting firm offering testing, clinical research, and quality/regulatory services — comparable target market with broader in-house lab capabilities.
• Regulatory Compliance Associates (RCA): Life sciences regulatory, quality, and compliance consulting firm serving medical device, pharma, and biotech companies with audit, remediation, and submission services — closely comparable boutique consultancy with similar talent-driven model.
• RQM+ (formerly R&Q Consulting): US-headquartered regulatory affairs and quality assurance consultancy for medical devices and IVDs, offering MDR/IVDR transition, FDA submissions, QMS, and clinical evaluation services — a near-direct competitor with overlapping service lines and similar talent-led boutique model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/gemarmed

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 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 GemarMed srl