Scientific Support Services for Medical Devices

Intertek is a leading provider of scientific support services, having both the specialized instrumentation and expert capability to conduct chemical and physical analysis of medical devices at all stages of the design, trial and manufacturing processes.

Our scientific services uniquely address the fields of metals, polymers and pharmaceuticals, and provide both long term scientific research and rapid response problem solving, including GLP certification, cGMP compliance and ISO 17025 accreditation.

 

R&D Analytical Support

Intertek’s significant expertise in bioanalysis and clinical pharmacokinetic studies allows us to support medical device companies working in the areas of preclinical and clinical drug development. Our support services include assay development for API’s, impurities, trace metals and degradants. We help determine residual solvents such as volatile organic compounds (VOCs) and organic volatile impurities (OVIs). We assess physical / chemical properties and have extensive capabilities for extractables and leachables testing - including metals, polymer components and the evaluation of packaging materials.

Material Characterization and Failure Analysis

Intertek’s extensive materials science laboratories offer analytical services for implantable medical devices and healthcare products. Typical analytical approaches to problem-solving include fracture and failure analysis, surface chemistry and adhesion, microstructure and mechanical property relationships, chemical imaging, and materials deformulation.

Interaction Assessments in Combination Devices

Intertek offers assay development for API-device interactions and material compatibility, the evaluation of product interactions with packaging materials, and identification of trace impurities or degradation pathways.

Stability and Medical Device Testing

Comprehensive capabilities to evaluate batch release, slow elution, low solubility dissolution, and controlled drug release patterns (DRP) with on-site stability and storage facilities that include walk-in chambers for ICH conditions and reach-in chambers for special storage conditions. Intertek laboratories are equipped to detect the smallest traces of substances of concern in both drug compounds and polymeric materials.

Regulatory, Auditing and Microbiology Services

Intertek pharmaceutical and clean air services provides clean room validation, cGMP QA Auditing and instrument validation / calibration services. We also cover the EU RoHS Directive, the EU Biocide Directive, carry out cGMP microbiological evaluations and assess antimicrobial efficacy at a number of locations worldwide. Our toxicological experts work in close collaboration with our pharmaceutical and materials scientists to provide a truly comprehensive expert service.

Manufacturing Crisis and Rapid Response

Our scientists and auditors extend your local problem-solving capability by having corrosion scientists, metallurgists, polymer scientists and pharmaceutical specialists on call. Intertek’s medical device network reacts exceptionally quickly and efficiently to manufacturing issues or in-field customer complaints. And being truly independent our clients find our patent infringement investigations and scientific legal advisory services highly informative and readily submissible to both customers and regulatory bodies alike.

 

 

Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.

Need help or have a question? +1 413 499 0983
 

Need help or have a question?

+1 413 499 0983
Wilton UK:
+44 1642 435 788
Benelux:
+31 88 126 8888
France:
+33 (0) 385 99 12 80
APAC:
+65 6805 4800
Germany:
0800 5855888
+49 711 27311 152
Switzerland:
+41 61 686 4800
Mexico:
01 800 5468 3783
+52 55 5091 2150
Brazil:
+55 11 2322 8033
Australia:
+61 1300 046 837
India:
+91 (22) 4245 0204
 

Medical Device Testing and Certification