SIRIM Berhad | Life Science Centre | Medical Devices
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SIRIM Berhad | Life Science Centre | Medical Devices
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Lab Biography
In general, SIRIM Life Science Centre (LSC) provides testing services to support product regulatory compliance. We support industry in safety, quality & efficacy validation/verification of products & ingredients, which include pharmaceuticals, medical devices, health supplement, food products, chemicals, etc.
It can be commercial services or contract projects.
At LSC, for testing medical devices, we offer material characterization, microbiology tests, stability study, and biocompatibility/safety testing (in vitro/animal). And our labs are ISO 17025 accredited & GLP certified.
Also, in SIRIM Berhad, other department/division offers performance testing of In Vitro Diagnostics (IVD), medical equipment, and packaging validation, etc.
If you plan to import, manufacture or distribute MD products in Malaysia,
SIRIM is a Conformity Assessment Body (CAB) that support related Quality MS certification & product licensing with local regulator.
Tell me how I can help you. Let’s connect.
HANG Chong Yee, PhD
Researcher-Consultant | Business Development | Project Lead/Manager
Qualifications
ISO17025 accredited labs
OECD GLP certified test facilities
Animal (in vivo) testing facilities – Preclinical
Standards & Methodologies
ISO standards: ISO10993 series, ISO14971, ISO13485, GDPMD
International Council for Harmonization (ICH)
Pharmacopoeia
OECD Test Guide
ASEAN Guidelines
Industry Types Served
- Food & Beverage Products
- Medical Devices & Healthcare Products
- Pharmaceuticals & Biopharmaceuticals
Lab Testing Types Offered
- Chemistry & Compound Analysis
- Food Science & Nutritional Analysis
- Genetics & Genomic Testing
- Materials Evaluation & Testing
- Microbiology & Pathogen Detection
- Pharmacology & Drug Development
- Preclinical & Toxicology Studies
- Product Safety & Regulatory Compliance
- Safety Certification & Testing
- Toxicology & Biocompatibility Testing