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ISO 13485 is indispensable in the medical device business. BioReg can build a complete ISO 13485-compliant Quality Management System (QMS) for your company or only review your current QMS and SOPs. We can also prepare you for the ISO 13485 audit. Besides ISO 13485, our team advises on MDSAP and FDA 21 CFR 820.
Requirements of ISO 13485 apply to medical device companies regardless of their size and type of products.
ISO 13485 specifies requirements for a quality management system where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
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The organizations can be involved in one or more life-cycle stages, including design and development, production, storage and distribution, installation or servicing of a medical device, and design and development or provision of associated activities (e.g., technical support).
Whether you want to operate internationally or expand locally, ISO 13485 certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. In addition, companies with this certification communicate a commitment to quality to both customers and regulators.
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