BIOSERV
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.
- Company typePrivate
- Founded1991
- HeadquartersRostock, Germany
- Headcount11–50
- GTM typeB2B
- OfferingServices
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.
BIOSERV firmographics
Firmographics- 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
BIOSERV industry classification
Industry- 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
Where BIOSERV is headquartered
LocationHeadquarters
- HQ city
- Rostock
- HQ country
- Germany
- HQ region
- Europe
Offices2 records
Markets served
BIOSERV business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales
Revenue model
- 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.
- 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.
- 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
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Hygiene Training and Follow-up Instruction per § 43 Infection Protection Act |
| Unit Pricing | Pay-as-you-go | Basic Labelling Knowledge for Packaged Products (Seminar) |
| Unit Pricing | Pay-as-you-go | Introduction to Biological Safety Assessment of Medical Devices (DIN EN ISO 10993) |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels1 record
BIOSERV product offering
Product offeringCore 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
Companies that use BIOSERV
Customer profileNamed customers1 record
Segments4 records
Ideal customer profiles4 records
BIOSERV technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
BIOSERV partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered minor.
- Lebensmittelverband Deutschland e.V.minorProfessional 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 PrüflaboratorienminorAssociation 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
BIOSERV competitors and assessment
Company assessmentBroad 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
BIOSERV social profiles
Digital presenceBIOSERV compliance and trust
Trust signalCompliance6 records
BIOSERV financial estimates
Financial estimateRevenue estimate
Valuation estimate
BIOSERV leadership team
Management profileNumber of profiles
Profiles1 record
BIOSERV funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
BIOSERV M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about BIOSERV
What does BIOSERV do?
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.
Is BIOSERV a public or private company?
BIOSERV is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was BIOSERV founded?
BIOSERV was founded in 1991. It employs 11 to 50 people.
Where is BIOSERV based?
BIOSERV is headquartered in Rostock, Germany, in the Europe region.
How does BIOSERV make money?
Three revenue lines are on record. Laboratory Testing Services are the primary driver. The others are training and Consulting Services and consulting Engagements.
Who are BIOSERV's main competitors?
Broad incumbents on record are LGC Group, SGS SA, WuXi AppTec, Intertek Group and TÜV SÜD. Direct peers are Eurofins Scientific, Charles River Laboratories, AGROLAB Group, Nelson Labs (Sotera Health) and BSL Bioservice Scientific Laboratories Munich.
Does BIOSERV have an API?
No public API is recorded for BIOSERV.
What industry is BIOSERV in?
BIOSERV's product category is Analytical Testing Laboratory Services. Its primary akta.pro industry code is HLAGADAL, Environmental Monitoring & Cleanroom Testing (GMP), with a secondary code of AFALAAAE, Environmental Monitoring & Hygiene Verification (Swabs, ATP, Pathogen Monitoring). Its NAICS code is 541380 and its SIC code is 8734.