Service

Eurofins BioPharma Product Testing Munich GmbH

Behringstr. 6/8 , 82152 Planegg
Germany

Telephone +49 89 899650-0
Fax +49 89 899650-11
info-munich@eurofins.com

Trade fair hall

  • Hall 8a / F26
 Interactive Plan

Hall map

COMPAMED 2016 hall map (Hall 8a): stand F26

Fairground map

COMPAMED 2016 fairground map: Hall 8a

Our range of products

Product categories

  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.03  Biocompatibility studies
  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.07  Haemocompatibility studies
  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.08  Hygiene studies
  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.09  Immunology studies
  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.10  Laboratory research services
  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.12  Microbiological studies
  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.19  Toxicology
  • 13  Services
  • 13.02  Testing, certification, quality assurance
  • 13.02.02  European "Medical Device Directive" 93/42 conformity assessment services
  • 13  Services
  • 13.02  Testing, certification, quality assurance
  • 13.02.03  Testing services

Our products

Product category: Biocompatibility studies, Haemocompatibility studies, Hygiene studies, Immunology studies, Laboratory research services, Microbiological studies, Toxicology, European "Medical Device Directive" 93/42 conformity assessment services, Testing services

Microbiology & Sterility

Whether validating terminal sterilization processes, or evaluating methods for cleaning and reprocessing reusable devices, Eurofins Medical Device Testing helps clients fulfill the stringent microbiological and sterility testing requirements needed for medical devices.

With more than 68,000ft2 of micro laboratory space, including six sterility suites, our team of highly skilled experts operate the most advanced microbial identification equipment.

Choose Eurofins Medical Device Testing to help you:

✔ Validate the sterilization of your terminally sterilized devices

✔  Conduct routine sterility testing for batch release testing or quarterly dose audits

✔  Validate cleaning and reprocessing procedures for reusable devices and instruments

✔  Evaluate water quality and/or environmental monitoring for your cleanroom operations

✔  Conduct routine endotoxin, bioburden and bacterial Identification or antimicrobial testing

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Product category: Biocompatibility studies, Haemocompatibility studies, Hygiene studies, Immunology studies, Laboratory research services, Microbiological studies, Toxicology, European "Medical Device Directive" 93/42 conformity assessment services, Testing services

Packaging & Seal Integrity

Once you have validated the design and functionality of your medical device, there are a myriad of testing requirements needed to ensure your product reaches the end user intact. From primary seal testing through pallet-level transit testing, our state-of-the-art package testing facility provides complete capabilities for evaluating every aspect of your package and labeling configurations, to ensure your product will survive the rigors of being transported around the world.

Choose Eurofins Medical Device Testing to help you:

✔  Validate new package designs

✔  Evaluate new packaging materials

✔  Assure the integrity of your sterile barrier

✔  Establish the shelf-life of your product

✔  Confirm freeze / thaw performance

✔  Verify that your UDI barcodes will remain scannable throughout transit

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Product category: Biocompatibility studies, Haemocompatibility studies, Hygiene studies, Immunology studies, Laboratory research services, Microbiological studies, Toxicology, European "Medical Device Directive" 93/42 conformity assessment services, Testing services

Combination Products

The process of bringing together bio/pharmaceuticals and medical devices to create a combination product requires specific testing on all product constituents. Eurofins Medical Device testing is well versed in the vast testing requirements and regulatory guidelines for bio/pharmaceutical products, as well as medical devices and offers comprehensive testing services for these components, both individually and combined.

From prefilled syringes, to drug coated implants and cell seeded scaffolds, our expertise covers the full range of testing needs for virtually any type of combination product.

Choose Eurofins Medical Device Testing to help you:

✔  Assess the chemical interactions among the constituents of your combination product

✔  Determine cellular viability and long-term stability of your product under a range of environmental conditions

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Product category: Biocompatibility studies, Haemocompatibility studies, Hygiene studies, Immunology studies, Laboratory research services, Microbiological studies, Toxicology, European "Medical Device Directive" 93/42 conformity assessment services, Testing services

Medical Electrical Equipment

Worldwide medical devices are controlled by strictly adjusted regional approval procedures, which also typically require testing by approved laboratories. In the field of active medical devices, these requirements are documented and internationally harmonized under the standard family IEC 60601. Currently, the IEC 60601-1 3rd edition is the base for the approval procedure of medical electrical equipment in most regulatory frameworks all over the world. Due to identical requirements of EN 60601, the IEC defines the assumption of conformity to MDD 93/42/EEC.

Eurofins Medical Device Testing performs testing according to IEC/EN 60601 standards for medical electrical equipment and documents the results in test reports and test certificates. We are supervised by regular inspections of the IEC Assessors and documented within the listing on the IECEE Website with the following scope of accreditation:

IEC 60601-1 (2nd and 3rd Edition) Basic standard
IEC 60601-1-2 EMC
IEC 60601-1-4 and IEC 62304 PEMS
IEC 60601-1-6 and IEC 62366 Usability
IEC 60601-1-8 Alarms
IEC 60601-1-11 Home Health Care Environment
IEC 60601-2-10 Stimulation
IEC 60601-2-27 ECG
IEC 60601-2-31 External Pacemaker
IEC 60601-2-40 EMG
IEC 60601-2-49 Patient Monitoring
IEC 60601-2-66 Hearing Aids
Choose Eurofins Medical Device Testing to help you:

✔ Check basic safety and essential performances

✔  Ensure conformity to IEC/EN 60601 standards

✔  Document test results in test reports and certificates

✔  Get CB test reports and certificates

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Product category: Biocompatibility studies, Haemocompatibility studies, Hygiene studies, Immunology studies, Laboratory research services, Microbiological studies, Toxicology, European "Medical Device Directive" 93/42 conformity assessment services, Testing services

Notified Body Services

In order to legally sell products in the EU market, medical device manufacturers must earn a CE mark to confirm compliance with the Medical Device Directive 93/42/EEC and supplementary Directive 2007/47/EC (MDD) to be classified according to potential risks associated ( Class I, II and III products).

Eurofins Medical Device Testing operates a Notified Body authorized to award EC certification (NB n.0477) for active and non-active medical devices in accordance with Directive 93/42/EEC to help clients obtain products that are safe and highly functional, offering reproducible and controlled quality.

We work with product designers and manufacturers to perform risk evaluations and necessary assays in order to certify the product.

Choose Eurofins Medical Device Testing to help you earn:

✔  EC Type Examination certificates (Annex III)

✔  EC Verification certificates (Annex IV)

✔  EC Declaration of Conformity – Production quality assurance (Annex V)

✔  EC Declaration of Conformity – Product quality assurance (Annex VI)

✔  EC Declaration of Conformity – Full quality assurance system (Annex II)

Certifications Offered:

Notified Body n° 0477 for CE certification in accordance to 93/42/EEC Directive, both for Active and Non-Active Medical Devices
Certification Body n° 133A according to ISO 13485 Scheme (Quality Management System for Medical Devices).

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About us

Company details

Eurofins BioPharma Product Testing Munich GmbH
With more than 30 years of experience and thousands of GMP/GLP studies per year Eurofins BioPharma Product Testing Munich GmbH (formerly BSL Bioservice Scientific Laboratories GmbH) supports its clients especially in the fields of bioassays, microbiology, in vitro toxicology, pharmacology, and biocompatibility. Immunoanalytical and bioanalytical studies are offered as support of non-clinical and clinical programs. Eurofins BioPharma Product Testing covers the whole range from standardized test to special requirements and tailor-made studies.
In addition to the pharmaceutical industry, Eurofins BioPharma Product Testing Munich serves customers in the medical device, agrochemical and chemical industries.
Eurofins BioPharma Product Testing Munich has been certified in accordance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) and has been accredited with DIN EN ISO 17025 for the testing of medical devices.
The company is listed by the World Health Organization (WHO) and has been audited successfully by the FDA.

Services
for Medical Devices
• Biocompatibility Testing
• Cytotoxicity Tests
• Sensitization Studies
• Irritation Studies
• Hemocompatibility Testing
• Microbiological Testing
• Implantation Studies (in collaboration with partner laboratory)

for Pharmaceuticals, Biologics & ATMPs
• Process and Product Related Impurities
• Bioassays
• Method Development & Validation
• Stability & Release Testing
• Sterile & Non-Sterile Product Testing
• Leachables & Extractables Testing
• Immunoanalytical Studies
• Bioanalytical Studies
• in vitro Toxicology Studies
• Pharmacology Studies

for (Agro)chemicals, Cosmetics & Food Additives
• Irritation Studies
• Sensitization Studies
• Local Tolerance Studies (in collaboration with partner laboratory)
• Genetic Toxicology

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Company data

Sales volume

10-49 Mio US $

Number of employees

100-499

Foundation

1984