ISTA Certified Laboratory | www.boelnordic.com

Packaging and medical device testing

Our partner paconsult Meditec delivers the highest quality service, ensuring on-going communication and confidentiality at all times.

Whether your medical device test requirements are routine, or customisations of standard tests, or you require the development of new tests to meet your bespoke applications, We has the technical capability and experience to assist you.

We have a totally up to date knowledge of, understanding of and adherence to the pertinent regulations and standards stipulated by the FDA, the European Medical Device Directive, ISO 11607.

We also understand that our clients successful compliance may require a combination of these and other relevant regulation depending on where in the world the product is to be distributed.

Your product will be tested in accordance with international and national standards and internal specifications: Flow measurement, tensile- and compression testing, bending and kink behaviour, gravimetric measurements, dimensional accuracy and visual inspection.

For special medical devices, new methods for mechanical functional testing can be developed and validated.

Dye Penetration Testing | www.boelnordic.com

Sterile products by validated packaging

For validation of the packaging process we offer individual solutions for the implementation of the Operation Qualification (OQ) and Performance Qualification (PQ) in accordance with ISO 11607-2 and support you in the definition and implementation of revalidation.

  • Environmental Testing
  • Transportation Testing
  • Dye Penetration
  • Bubble Leak Testing
  • Vacuum Testing
  • Burst Testing
  • Peel Testing / Seal Strength
  • Microbial Challenge Testing
  • Cold Chain Testing
  • Accelerated and Real Time Ageing
Seal Strength Testing | www.boelnordic.com

Packaging- and material testing

  • Integrity Testing
  • Seal Strength Testing
  • Shelf-life Studies und Accelerated Ageing
  • Transport Simulation Tests
  • Packaging Material Testing

Product reliability testing

Boel Nordic can facilitate product reliability testing using trusted testing experts and internationally recognised standards. Tests can be applied for the medical industry within:

  • HALT / HASS
  • Thermal Shock Testing
  • Humidity Testing
  • Vibration Stressing
  • Mechanical Shock and Bump Testing
  • High / Low Temperature Cycling
  • High Temperature Stressing
  • Low Temperature Stressing
  • Water Ingress Testing
  • Dust Testing
  • Altitude Testing
  • Accelerated Corrosion Salt Mist / Spray Testing
  • Transportation Testing
Drop Test Equipment | www.boelnordic.com

Packaging & transportation testing

Package and transportation testing is carried out to determine how a packaged product will perform under simulated conditions. This suite of tests will determine if the packaging and cushioning materials being used will protect its contents while being transported and stored.

The tests that will simulate the typical hazards your package will routinely encounter in the distribution cycle:

  • Climatic Conditoning
  • Drop and Incline Testing
  • Compression Testing
  • Vibration Testing
  • Altitude Testing