Complete Laboratory Solutions
Medical Device
Testing Services / Medical Device
CLS provides specialised Microbiological and Analytical testing services to the medical device industry, ensuring the highest standards of safety, sterility, and compliance. With advanced laboratory capabilities, we offer microbiological testing to detect potential contaminants, including bacteria, fungi, ensuring that devices meet stringent sterility requirements. Our analytical testing identifies harmful substances, residues, and leachables that could affect patient safety or device functionality. By outsourcing to CLS who have significant experience and advanced capabilities, medical device companies can ensure thorough, reliable testing while focusing on their core competencies. Partnering with CLS for both microbiological and analytical testing, supports medical device manufacturers in meeting regulatory standards, optimising product quality, and ensuring the safety and efficacy of their devices in healthcare environments.
Medical Device Industry Testing
Microbiological
Microbiological testing completed by CLS plays a vital role for medical device companies in ensuring the safety, sterility, and quality of their products. This testing is essential for detecting and controlling microbial contamination in raw materials, finished products, and manufacturing environments. Our GMP laboratory adheres to strict regulatory standards, such as FDA, HPRA and ISO. Partnering with CLS for Microbiological testing ensures compliance, product integrity, patient safety, clean room validation (EMPQ) making it a key aspect of quality control.
Routine Microbiological Testing
- Bioburden analysis
- Microscopic ID’s in supporting product and clean-room monitoring
- Bacterial yeast and mould, Malditoff and PCR analysis
- Endotoxin Testing (LAL), both gel clot and chromogenic methods available
- Absence of specific organisms
- Media fill
Environmental Monitoring Process Qualification (EMPQ)
- Microbial assessment and monitoring
- Bioburden and endotoxin assessment
- Development and validation of test methods
Stability Testing & Storage
Our range of services includes ICH Stability storage facilities that are fully supported by our GMP operating Analytical Chemistry and Microbiology Laboratories. We have extensive experience in working with many dosage forms, drug substances and excipients.
Customer Benefits
- Testing delivered to you on your terms
- Capacity always available to you for planning and execution
- Depending on a company rather than your individuals, no sick time or holiday time required
- Cost-effective solution
- Allows you to focus on manufacturing – your value proposition not testing that’s ours
- Access to expediate results
- We manage the compliance of your testing and we host the audits
- We can manage your analyst recruitment screening, technical training, and succession planning and backfilling – no downtime.
Chemical & Analytical
Our Chemical and Analytical Testing Services for the medical device industry ensure that products meet the highest standards of safety, quality, and regulatory compliance. We offer comprehensive testing solutions, including the analysis of extractables and leachables, material characterization, residue analysis, and identification of contaminants or harmful chemicals. These tests help verify the biocompatibility of materials used in medical devices, ensuring that no harmful substances are released during use that could compromise patient safety or product performance. With our advanced laboratory capabilities and adherence to FDA, HPRA, ISO, and other regulatory guidelines, we support manufacturers in maintaining product integrity and meeting stringent industry standards.
Routine Analytical Testing
- Water Testing
- Raw Material Testing
- Pharmacopoeias Testing – European, United States, BP, JP, ChP.
- Finished Product Testing
- Cleaning and Detergent Testing
- QC Release Testing
Stability Testing & Storage
- Retain sample testing and storage
Validation Projects
- Method Transfer
- Method Development
- Analytical Method Verifications
- Cleanroom Validation
Technical Consultancy
- Project based or ongoing
ONLINE RESULTS AVAILABLE 24/7
FLEET OF REFRIGERATED VEHICLES
Managed services on client sites
Highly ACCREDITED LABORATORY
Expert Customised Technical Support
of our clients would recommend us
CLS FlexiQ
Flexible Managed Quality Services
CLS builds strategic partnerships with its clients to deliver a flexible and managed quality solution.
Flexible managed quality service (FlexiQ) provides a seamless solution by supplying organisations with highly skilled, work-ready quality professionals on a temporary, project-specific, or long-term basis.
This service can be provided at a CLS site or directly at the client's location. CLS builds strategic partnerships with its clients to deliver a flexible and managed quality solution.
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