Medical device testing

We offer pre-clinical testing and consulting services of medical devices. We have our own laboratories that are among some of the most modern in all of Europe and we are proud to say we have a very broad field of tests we are able to conduct. We are not exaggerating by saying that to us nothing is impossible! We always advise our customers good and cost-effective solutions.

Biocompatibility of medical devices has to be evaluated in the view of the ISO 10993 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”. The biological test methods applicable for respective medical devices are classified in regard to their nature and duration of contact.

The list of medical device tests that we conduct on site:

Biocompatibility

Cytotoxicity ISO 10993-5
- MEM Elution
- Direct contact
- Agar diffusion
- Filter diffusion
- MTT/XTT
- Neutral Red Uptake

Sensitization ISO 10993-10
- Guinea pig maximization test (GPMT, Magnus-Kligman Maximization)
- Closed-patch (Buehler)
- Murine Local Lymph Node Assay (LLNA)

Irritation or Intracutaneous reactivity ISO 10993-10, ISO 10993-23 additionally:
- Ocular irritation
- Oral mucosa irritation
- Penile irritation
- Rectal irritation
- Vaginal irritation
- In vitro irritation

Material mediated pyrogenicity ISO 10993-11
- Endotoxin LAL
- Rabbit pyrogen test

Acute systemic toxicity ISO 10993-11
Subacute toxicity ISO 10993-11
Subchronic toxicity ISO 10993-11
Chronic toxicity ISO 10993-11

Implantation ISO 10993-6
- Subcutaneous
- muscle
- bone
- brain
- relevant clinical site

Hemocompatibility ISO 10993-4
- Hemolysis
- Coagulation
- Platelet activation
- Complement
- Hematology

Genotoxicity ISO 10993-3, ISO 10993-33
- Bacterial reverse mutation assay (AMES)
- Mouse Lymphoma Assay (MLA)

Carcinogenicity ISO 10993-3

Reproductive/developmental toxicity ISO 10993-3

Degradation ISO 10993-13, ISO 10993-14, ISO 10993-15, ISO 10993-16

Immunotoxicology ISO 10993-20

Nanomaterials ISO 10993-22

Chemistry (Extractables and leachables)

Physical and/or chemical information ISO 10993-18
- Headspace GC-MS
- GC-MS
- LC-MS
- ICP-MS
- FTIR
- UV/VIS Spectroscopy USP <197>

Toxicological risk assessment ISO 10993-17

Microbiology and sterility testing (ISO 11737-1, ISO 11737-2)

Bacteriostasis & Fungistasis (Method Suitability) USP <71>
Bioburden method validation USP <1227>
Bioburden testing USP <61>
Sterility testing USP <71>

Package validation

Bubble emission ISO 11607, ASTM F2096
Dye migration ISO 11607, ASTM F1929
Burst ISO 11607, ASTM F1140
Seal strength ISO 11607, ASTM F88
Accelerated aging ASTM F1980

Reprocessing validation

Automated cleaning ISO 17664, ISO 15883-1, ISO 15883-5, ASTM 2314, ISO 7864, ISO 10993-5
Manual cleaning ISO 17664, ASTM 2314, ISO 7864, ISO 10993-5
Disinfection ISO 17664, ASTM 1837, ISO 10993-5
Steam sterilization ISO 14937, ISO 17665-1

Consulting services of medical devices

Biological Evaluation Plan (BEP)
Biological Evaluation Report (BER)
Risk analysis
Clinical evaluation
Instruction for Use
Certification strategy

If you need any test for you medical device, just let us know – we will help you on your way!

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