Medical Device Materials Failure Analysis
Medical Device materials failure analysis supports manufacturers of implantable medical devices and related healthcare products.
Intertek's material scientists are experienced in solving a wide range of material-related problems associated with the manufacture and operation of implantable medical devices, such as catheters and stents. Typical medical device material failure investigations include:
- Root cause investigations associated with FDA incidents or patient fatalities (devices /catheters / stents / delivery mechanisms)
- Cardiovascular (pre- and post-production) product contamination investigations
- Manufacturing and supply chain auditing following gastro-pulmonary device production outages
- In-process investigations aimed at improving neurovascular product manufacturing yields
- Co-working with polymer raw material suppliers to improve quality input into final production materials
Analytical approaches to medical device problem-solving include:
- Fracture and failure analysis of medical devices and associated materials
- Surface chemistry and adhesion of product bonds
- Microstructure and mechanical property relationships
- Chemical imaging and phase distribution of actives
- Materials deformulation and validation for QC
Need help or have a question?
North America Laboratories:
- Intertek Allentown
7201 Hamilton Blvd
Allentown, PA USA
Tel: +1 610-295-0148
Email: asa@intertek.com - Intertek Pittsfield
50 Pearl Street
Pittsfield, MA 01201
Tel: +1 413-499-0983
Email: iptl@intertek.com
WHITE PAPERS
- Adhesives QA Testing Programs
- Food Contact & Non-Intentionally Added Substances (NIAS)
- The DoC and Regulation 10/2011 for Plastic Food Contact Materials
- Regulation EU 2020/1245 To Amend Regulation EU 10/2011
WEBINARS
- PFAS Monitoring in Environmental and Polymer Samples
- Microplastics and Nanoparticles - Definitions And Regulatory Considerations
- Microplastics and Nanoparticles and Food Contact Applications
CASE STUDIES
- Dissolution of Hydroxyapatite Coatings for Medical Devices
- Particulate Contamination control and analysis
- Polymer Rheology Testing Case Study