Testing for Medical Devices

Manufacturers of medical devices must perform several tests on their devices to ensure they are effective, safe, and marketable in the European Union.

We can perform a wide range of tests for your medical devices following the latest scientific developments and complying with EU standards and regulatory requirements.

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The Representative of choice for

  • Extrusion force of pureed products
  • Hardness and strength testing
  • Film integrity for seals and packaging
  • Cake strength
  • Spread force
  • Evaluation of inhaler performance
  • In vitro Eye Irritation OECD 492
  • In vitro Skin Irritation OECD 439
  • In vitro Skin Corrosion OECD 431
  • In vitro Inhalation Toxicity Test
  • Biological evaluation – Part 5: Tests for in vitro cytotoxicity ISO 10993-5
  • Biological evaluation — Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity ISO 10993-3
  • Chemical analysis and assays
  • Method development, validation, and identification
  • Quantification of degradation products
  • Extractables and leachable studies
  • Testing for traces and impurities
  • Challenge test
  • Microbial testing
  • Stability and shelf life testing
  • Product photostability

Compliance Success Stories

Why Obelis?

Our deep and long-standing experience with Swiss, EU and UK compliance frameworks makes us the best choice to support your products’ path towards compliance in these territories.

Our team regulatory experts will guide you through medical devices’ technical documentation, notification, labelling, among others.

About us
Founded in 1988, we are among Europe’s largest centres for advisory and representative services.
We are certified by ISO 9001:2015 and ISO 13485:2016.
We have helped over 3,000 manufacturers from over 60 countries address their regulatory challenges.
We are members of professional associations and more than 10 European Commission working groups.
Obelis International Offices (OIO) comprise independent partners providing solutions in other global markets.
Our team consists of lawyers, chemists, pharmacists, and other experts. Our close-knit culture has been certified by the Great Place to Work Survey 2022-23.