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In Vitro Diagnostic Medical Devices in Europe by CE Marking. Click here to get FREE Guide. Your One-Stop Information Source -. CE mark approval, CE testing, CE mark requirements, etc. This website is the property of Wellkang Tech Consulting.
Medical device companies need to establish a Quality System to meet regulatory requirements. CQ has a proven track record in developing Quality Systems to meet FDA scrutiny and obtain ISO 13485 certification. Regardless of the market for your medical device, there are regulatory and compliance concerns that you must address. On the compliance side, our knowledge and experience with FDA inspections and ISO audits should be an asset to your company.
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