What QUASER S.r.l. does

QUASER S.r.l. is an Italian private limited company (S.r.l.) operating as a regulatory compliance and quality certification consultancy, headquartered in Rome (Via Pian due Torri 19, 00146) with a secondary office in Potenza Picena (Marche region). Founded in 1988 and operating for over 25 years, the firm serves companies seeking certification and regulatory access across five service lines: medical devices (CE marking under EU MDR 2017/745), in vitro diagnostics (IVDR compliance), business certifications (ISO 9000 family and ISO 13485:2016 quality management systems), FDA records (US market registration for medical devices and food products), and cosmetics regulatory compliance. The company is staffed by qualified engineers who maintain continuous contact with Italian and EU regulatory bodies, and positions itself as one of the few Italian firms offering complete FDA registration assistance for both medical devices and food products.

The underlying technology is purely advisory in nature; QUASER sells expert human consulting rather than a software platform, automation tooling, or proprietary technical asset. The business model is professional services: client engagements are direct consulting mandates scoped to certification and compliance projects, priced via contact-based quotations with no publicly disclosed fee schedules, and delivered through the firm's two Italian offices. Marketing is conducted through a bilingual (Italian/English) website and ongoing regulatory news content covering ISO, EU MDR/IVDR, FDA, and GDPR developments, supported by direct contact channels (phone, email, contact form). Customer segmentation is vertical, organized by regulated product category rather than by company size or industry.

The firm operates as a micro-consultancy with 22 employees, no disclosed funding, no parent company, no subsidiaries, and no disclosed management team in the source material. Revenue is not publicly reported. Ownership is described as founder- or management-owned, with no institutional investment identified. Geographic scope is limited to Italy-based client engagement, with services extending to US market access via FDA registration work, though no explicit global footprint is claimed.

Name

QUASER S.r.l.

Legal name

QUASER S.r.l.

Website

https://quasersrl.it

Company type

Private

Founded year

1988

Operating status

Operating

Headcount range

11–50 employees

Short description

QUASER S.r.l. is an Italian regulatory compliance and quality certification consultancy that assists medical device manufacturers, IVD companies, cosmetics producers, and general businesses with ISO 9000, ISO 13485:2016, CE marking under MDR 2017/745, and FDA registration services.

Ownership category

akta.pro rank

Product category

Regulatory Compliance Consulting

NAICS

Other Scientific and Technical Consulting Services (54169)

akta.pro primary industry

Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI)

akta.pro secondary industries

Regulatory Intelligence, Labeling & Promotional Compliance (HLAGAKAN), Regulatory Consulting & Compliance Program Management (FDA/USDA/EFSA) (AFALADAC), Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC)

Keywords

• Regulatory compliance consulting
• Medical device compliance
• CE marking services
• ISO 13485 certification
• FDA registration services

Headquarters

HQ city

Rome

HQ country

Italy

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Professional Consulting Services: Consulting services for regulatory compliance, quality certification, and business certification. Services include assistance with ISO 9000 certification, ISO 13485:2016 certification, CE marking for medical devices, FDA registration, IVD compliance, cosmetics compliance, food supplements compliance, H.A.C.C.P., privacy management, and inspection services.

Distribution channels1 record

Marketing channels3 records

Core offering

QUASER S.r.l. is an Italian regulatory compliance consulting firm that assists manufacturers of medical devices, in-vitro diagnostics (IVD), cosmetics, and food supplements with regulatory requirements for the EU and US markets. The firm delivers ISO 9000 and ISO 13485:2016 quality management system consulting, CE marking under EU Medical Device Regulation 2017/745, FDA registration support, EUDAMED database registration, and GDPR compliance advisory. Services are delivered on a project basis directly to manufacturing clients.

Product overview

QUASER S.r.l. is a consulting firm operating for over 25 years in company certification and regulatory compliance services. The company provides a portfolio of advisory services organized around five core offerings: Medical Devices (CE marking and MDR 2017/745 compliance), IVD (In Vitro Diagnostics under IVDR), Business Certifications (ISO 9000 family), FDA Records (US market registration), and Cosmetics regulatory compliance. These services are delivered through direct consulting engagements rather than software products.

Differentiator

Problem solved

Functional benefit

Products and services

• CE Marking under EU MDR 2017/745

Segments5 records

Ideal customer profiles2 records

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Scale indicators2 records

Recent moves4 records

Expansion highlights3 records

Direct peers

• MedEnvoy: Boutique consulting firm specializing in FDA registration and US agent services for medical devices and food products — directly mirroring QUASER's niche FDA-registration capability.
• Emergo by UL: Global regulatory consulting firm specializing in medical device, IVD, and combination-product market access, including CE marking, FDA registration, and ISO 13485 — directly overlapping QUASER's core medical-device, IVD, and FDA-registration services.
• NAMSA: Medical-device-focused contract research, testing, and regulatory consulting organization with strong FDA and EU MDR expertise; directly comparable to QUASER's med-device/IVD regulatory service lines.
• RQM+: Specialized medical device regulatory and quality consulting firm providing FDA, CE marking, ISO 13485, and EUDAMED support — a near-direct peer to QUASER's medical device and FDA registration practice.

Broad incumbents

• Intertek: Global TIC company offering medical device, IVD, and consumer product testing plus regulatory and quality support; comparable to QUASER on multiple regulated-vertical certifications.
• NSF International: Global public-health and safety organization offering medical device regulatory consulting, ISO 13485 certification, and testing services; competes with QUASER on medical-device compliance and ISO certification.
• Bureau Veritas: Global TIC company with a healthcare and consumer-products practice covering medical device, cosmetics, and ISO 9001 certification; comparable to QUASER's diversified regulated-vertical mix.
• SGS: World-leading testing, inspection, and certification company with medical-device, IVD, cosmetics, and food regulatory services that directly overlap with QUASER's five service lines, though at vastly greater scale.
• BSI Group: One of the world's leading notified bodies for medical devices and IVDs and a major ISO certification body; competes with QUASER on the CE-marking/ISO 13485 side while operating globally with much broader scale.
• TÜV SÜD: Global notified body and TIC company providing CE marking, ISO 13485, and regulatory consulting for medical devices; overlaps with QUASER's med-device service line as a much larger incumbent.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks7 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/quasersrl

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 QUASER S.r.l.