The design, manufacture and distribution of in-vitro diagnostic test kits, used in the diagnosis of disease status, autoimmune status, coagulation, and transmissible agents.
The registration covers the quality management system for the design, production, commercialization and technical support (including training) of analytical instruments based on optical emission, x-ray and automation solutions. Thermo Fisher Scientific (Ecublens) S.A.R.L.Įn Vallaire Ouest C | CH-1024 Ecublens Switzerland Local Authorized Representative, Import, Storage and Handling, Warehousing, Distribution (including transportation), Installation, Testing & Commissioning, Maintenance & Calibration and Documentation (including traceability) of medical devices as listed in Annex 1.
Sub-contract irradiation of customer products to customers specifications per ISO 11137. Manufacturing of nucleotides for research, in vitro diagnostics and further manufacturing.ĭevelopment, manufacture and sterilization by irradiation of Laboratory plastic equipment. Production of liquid chromatography (LC) columns and supply of accessories through the phases of material reception, mixing of chemical products with absorbent elements placing the elements in the columns, mounting of accessories, pressing, quality testing, cleaning, packing and shipping.ĭesign, development, manufacturing and sales of life science research products, including proteins, nucleic acids, nucleotides, antibodies, bio-sample preparation, cell separation reagents and associated kits, liquid chromatography (LC) columns and supply of accessories for research or further manufacturing of therapeutics or in vitro diagnostics. Research, design, development and manufacturing including fermentation, purification, bio formulation, organic synthesis, dispensing, assembly, shipping of life science research products, including proteins, nucleic acids, nucleotides, master mixes, antibodies, bio-sample preparation and cell separation reagents and associated kits, for research and in-vitro diagnostics including processes under aseptic conditions. Manufacturing of nucleotides for in vitro diagnostics and further manufacturing. Here is a collection of our carefully prepared ISO 13485 audit checklists you can browse and use as part of achieving ISO 13485 certification and ongoing compliance.Design, development and manufacturing and distribution of in vitro diagnostic assay components, products intended for ex-vivo separation of human cells, and for cell-based clinical research and of reagents used for life science applications.ĭesign, development, and manufacturing of reagents, proteins, nucleic acids, nucleotides, antibodies, associated kits, and materials intended for ex-vivo separation of human cells for in vitro diagnostics, for further manufacturing and applied market applications, including processes under aseptic condition.
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Time spent on documentation and manual filing of records can be better spent working on gaps found in the current QMS and working towards getting certified for ISO 13485. Paper-based audits can be burdensome and time-consuming.