Independent and tailored medical device testing

No matter if you develop your own device or customise an off-the-shelf device, you can now reduce your test lead time by utilising NNE's test and regulatory expertise within combination product testing.

Through our ISO standard experts and device test laboratory, NNE provides a full range of regulatory and device test services to our customers. Our deep domain knowledge and combination product experience allow us to offer best practices within combination product testing. We cover all facets of testing, ranging from feasibility/explorative testing to full design verification testing using validated test methods, based on three key elements:

First-hand ISO standard and device test regulatory knowledge

Complying with standards is rooted in our DNA. As such, we provide and apply first-hand regulatory knowledge through our dedicated ISO standard experts.

Data-driven approach

Our test approach is data-driven and focuses on the independence throughout all performed device tests. That independence is important because the tested device is separated from the manufacturing process while tested. Hence, we can provide an independent verification of the device performance.

Robust test methods

We offer tailored testing, which means that we are flexible and will develop and validate unique test methods for your specific needs. We support your device development process from early feasibility testing through engineering testing to design verification.

Device testing

  • Torque and force test
  • Friction test
  • Free fall/drop test
  • Highly accelerated lifetime testing (HALT) and simulated ageing studies
  • Dose accuracy
  • Assembly force
  • Physical stability test
  • Comparability testing
  • Lifecycle testing

Primary container testing

  • Break loose and extrusion force
  • Container closure integrity
  • Impact testing
  • Siliconisation (micro dosing and spray)
  • Time pressure simulations and investigation
  • Filling and capping of primary container
  • Depyrogenation
  • Steam sterilisation
  • Leakage test
  • Transportation test
  • Viscosity measurement

Regulatory and compliance

  • ISO 11608-1, 2, 3 and 5 (needle based injection systems)
  • ISO 20069 device change assessment
  • ISO 80369-7 connectors
  • ISO 13485 QMS requirements for regulatory purposes
  • USP1207 package integrity evaluation

Analysis and development

  • Design of experiments (DoE)
  • Formulation of test media
  • In-house 3D printing
  • Rapid prototyping
  • Feasibility/engineering/verification testing (performance and functional testing)
  • High speed video analysis
  • Materials selection and custom polymer synthesis
  • Geometric verification
  • Microscope analysis
  • Test method development, qualification and validation

Book now!

Book now!

See if your device stands the test. Contact Laboratory Manager, Daniel Rojecki to book a time in our test lab.

Call: +45 3075 0094

Email
Take a tour of our device testing lab

Take a tour of our device testing lab

This video takes you on a virtual tour of our in-house device test laboratory and gives you a sneak peek of our different test equipment.

Watch it here

Meet the device test lab team

Daniel Rojecki

Daniel Rojecki

Daniel has 10+ years of experience bringing medical devices to market. The focus of his work ranges from industrialising product concepts to full product scale-ups. Daniel is a Danish Expert in ISO/TC84 and develops standard: ISO11608 (NIS) and ISO20069 (Device Change Management).

NNE contact person
ISO expert and committee member
Test method development and design verification testing

Carsten Schaufuss-Feddersen

Carsten Schaufuss-Feddersen

Carsten has 10+ years of experience in medical device quality assurance. He has developed and implemented procedures for combination products, design controls, risk management incl. developing FDA compliant approaches to human factors engineering, and facilitated use risk assessments.

Test strategies and best practices
Compliance testing regulatory clearance
AAMI committee member
Quality systems

Lars Stenholt

Lars Stenholt

Lars has extensive experience with medical device product development. This includes project management, early technology development, manufacturability as well as product approval for medical devices and pharmaceutical packaging.

Intellectual properties
Stakeholder management
Device development and performance

Michael Brun Jensen

Michael Brun Jensen

With a strong academic background (Ph.D.), Michael promotes data-driven decision making by ensuring scientifically valid product testing. He has more than seven years of experience with applied statistics and instrumentation for biomedical research and device testing.

Statistical test planning:
- Sample size estimation
- Design of experiments (DoE)
Statistical data analysis
Development and validation of test methods (including measurement system analysis/gauge R&R)

Zara Solsikke Berthelsen

Zara Solsikke Berthelsen

Zara has significant experience within tensile testing and container closure integrity testing with Helium leak detection. She has years of experience with work on primarily primary containers within a GMP or GLP regulated workspace.

Method development and validation

Design of experiments and statistical data analysis

Bjarke Lykke Ludvig Svendsen

Bjarke Lykke Ludvig Svendsen

Bjarke provides expertise within test fixture design and test equipment. He possesses deep experience from the metal manufacturing industry and extensive knowledge of manufacturing methods. 

Test fixture development:
- Mechanical design
- Prototyping
- First article inspection
3D-printing
Test method development