BIOSERV

What BIOSERV does

BIOSERV Analytik und Medizinprodukte GmbH is an independent, owner-managed testing laboratory founded in 1991 and headquartered in Rostock, Germany, with a second location in San Diego, USA established in 2024. The company provides accredited analytical and safety testing services across four core verticals: food and feed analysis, medical device and pharmaceutical testing (with a focus on ISO 10993 biocompatibility and MDR compliance), drinking water analysis, and environment and hygiene monitoring. It also offers GLP and GMP compliant laboratory services, alongside a training and consulting portfolio covering quality management, HACCP, toxicology, labelling, and regulatory compliance.

The laboratory operates under a multi-layered regulatory framework — DAkkS accreditation to DIN EN ISO/IEC 17025, GLP certification, GMP certification, FDA registration, ZLG authorisation, and ILAC membership — which makes its test reports internationally accepted by regulators such as the FDA and EMA. The technology stack centres on validated in-vitro and in-vivo testing methods for the majority of the ISO 10993 biocompatibility endpoints, complemented by a curated network of partner laboratories for specialised procedures; a 2024 digital transformation is migrating paper-based lab notebooks to a modern LIMS platform.

Commercially, BIOSERV runs a project-based professional services model with per-test and per-project custom quotations, supplemented by unit-priced public training seminars (e.g., €59 + VAT per participant for § 43 IfSG hygiene training). Go-to-market is direct: customers reach the lab via the company website, contact forms, and industry networks. The company serves more than 1,000 customers across regional, national, and international markets, spanning industrial producers, artisanal businesses, restaurants, caterers, retailers, logistics providers, healthcare facilities, and medical device and pharmaceutical manufacturers. Revenue, headcount (50+), and ownership structure (concentrated in the founder/management team, no external capital) point to a stable Mittelstand-style services firm rather than a venture-backed growth business.

Name

BIOSERV

Legal name

BIOSERV Analytik und Medizinprodukte GmbH

Website

https://bioserv.de

Company type

Private

Founded year

1991

Operating status

Operating

Headcount range

11–50 employees

Short description

BIOSERV is an independent, DAkkS-accredited, GLP/GMP-certified testing laboratory in Rostock, Germany, providing food, medical device (ISO 10993/MDR), pharmaceutical, water, and hygiene analysis, plus training and consulting, to over 1,000 customers across food, healthcare, and medtech sectors in Europe and the US.

Ownership category

akta.pro rank

Product category

Analytical Testing Laboratory Services

NAICS

Testing Laboratories and Services (541380)

SIC

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

akta.pro primary industry

Environmental Monitoring & Cleanroom Testing (GMP) (HLAGADAL)

akta.pro secondary industries

Environmental Monitoring & Hygiene Verification (Swabs, ATP, Pathogen Monitoring) (AFALAAAE), Bioprocess Safety, Biosafety & Contamination Control Solutions (single-use integrity, environmental monitoring) (HLAAAJAO), Food Safety Certification Bodies (ISO 22000, FSSC 22000, BRCGS, SQF) (AFALAAAC)

Keywords

• Biocompatibility testing services
• Medical device safety testing
• Food analysis laboratory
• Drinking water analysis
• Hygiene monitoring services

Headquarters

HQ city

Rostock

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Laboratory Testing Services: Fees charged for analytical and safety testing services including food analysis, drinking water testing, medical device biocompatibility testing, and hygiene monitoring. Revenue is generated on a per-project or per-test basis with individual quotation.
2. Training and Consulting Services: Fees charged for training programs and consulting services in food analysis, quality management, HACCP, labelling, toxicology, and biocompatibility evaluation. Training sessions are offered both in-house and online, with set pricing for public courses.
3. Consulting Engagements: Individual consulting engagements for quality management implementation, audit preparation, regulatory compliance support (EU approvals, MDR), and crisis management for food and pharmaceutical companies.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

BIOSERV is an independent, owner-managed accredited testing laboratory providing analytical and safety testing services for the food, medical device, pharmaceutical, and water industries. Its portfolio spans ISO 10993 biocompatibility testing, MDR-compliant medical device safety testing, food and feed analysis, drinking water analysis, hygiene and environmental monitoring, GLP/GMP-compliant laboratory services, and related training and consulting. Services are performed under DIN EN ISO/IEC 17025 accreditation, with results internationally recognised by regulators including the FDA and EMA.

Product overview

BIOSERV is an independent, owner-managed testing laboratory offering a comprehensive portfolio of laboratory and specialist services. The company operates as a unified testing services platform rather than a modular software product, providing biocompatibility testing (ISO 10993), medical device testing (MDR), food analysis, drinking water analysis, hygiene monitoring, GLP/GMP laboratory services, and training & consulting. These services are used by customers in healthcare, food industry, pharmaceuticals, and retail sectors for product safety verification and regulatory compliance.

Differentiator

Problem solved

Functional benefit

Products and services

• ISO 10993 Biocompatibility Testing
• Medical Device Testing (MDR)
• Food Analysis
• Drinking Water Analysis
• Hygiene Monitoring
• Training & Consulting
• GLP Laboratory Services
• GMP Laboratory Services

Quantifiable outcome

• Over 1,000 companies have selected BIOSERV as their testing laboratory of choice.
• +1 more outcomes

Named customers1 record

Segments4 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

Partnerships

Two partnerships are on record, tiered minor.

• Lebensmittelverband Deutschland e.V.minorOthersProfessional membership organisation for the German food industry. BIOSERV is a member, supporting its connection to the broader food industry regulatory and professional community.
• Deutscher Verband unabhängiger PrüflaboratorienminorOthersAssociation of independent testing laboratories in Germany. BIOSERV is a member, representing its position as an independent testing laboratory.

Scale indicators4 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• LGC Group: LGC is a UK-headquartered life-sciences measurement and testing services provider spanning reference materials, genomics, and analytical standards. Comparable as a broad incumbent whose analytical and quality-control testing offerings overlap with BIOSERV's regulated testing services.
• SGS SA: SGS is one of the world's largest testing, inspection, and certification companies. While SGS operates across many industries, its life-sciences and food testing divisions overlap with multiple BIOSERV service lines and serve similar regulated clients globally.
• WuXi AppTec: WuXi AppTec is a global CRO/CDMO with large-scale biocompatibility, medical device, and pharma testing capabilities. Comparable as a broad incumbent for regulated testing services serving the same international medical device and pharma client base that BIOSERV targets.
• Intertek Group: Intertek is a global TIC (testing, inspection, certification) incumbent covering food, pharma, medical devices, and environmental testing. Comparable as a broad incumbent whose portfolio overlaps with BIOSERV's analytical and safety testing scope.
• TÜV SÜD: TÜV SÜD is a major German-based TIC provider with strong medical-device and healthcare product testing capabilities. Comparable as a broad incumbent serving many of the same regulated German/European customers as BIOSERV.

Direct peers

• Eurofins Scientific: Eurofins is the largest independent food, pharma, and medical device testing platform globally with deep ISO 10993 and hygiene monitoring capabilities. It is the most direct head-to-head competitor for BIOSERV's regulated testing services across Germany and Europe.
• Charles River Laboratories: Charles River operates one of the largest global CRO/biocompatibility testing networks serving medical device and pharmaceutical clients under GLP. It competes with BIOSERV in the regulated, premium tier of biocompatibility and preclinical safety studies.
• AGROLAB Group: AGROLAB is one of Europe's largest independent food and environmental testing laboratories. It directly overlaps with BIOSERV's food analysis, drinking water, and hygiene monitoring service lines for European food-industry customers.
• Nelson Labs (Sotera Health): Nelson Labs is a leading global medical-device-focused testing lab for biocompatibility, sterilization, and packaging. It is highly comparable on ISO 10993 testing portfolio and serves an overlapping medical-device customer base that BIOSERV also targets.
• BSL Bioservice Scientific Laboratories Munich: BSL Bioservice is a German GLP/GMP-contracted lab specializing in biocompatibility, in-vitro, and in-vivo testing under ISO 10993. It competes head-to-head with BIOSERV for medical device safety studies across German-speaking markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/bioserv-analytik-und-medizinprodukte-gmbh

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 BIOSERV