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Iso 13485 2012 Certification Services In North America
9 services found
Manufactured by:HOBBS MEDICAL INC. based inSTAFFORD SPRINGS, CONNECTICUT (USA)
Manufacturers are facing two major hurdles these days. The first is workforce and the second is supply chain. It’s critical to partner with companies that can assist you in meeting the demands of your ...
Manufactured by:Tegra Medical based inFranklin, MASSACHUSETTS (USA)
To help ensure a smooth life cycle for your product we infuse quality into every step of the manufacturing ...
Manufactured by:Shiphrah Biomedical Inc. based inToronto, ONTARIO (CANADA)
Grow or cause to grow and become more mature, advanced, or elaborate. Start to exist, experience, or ...
by:Bureau Veritas North America, Inc. based inNew York, NEW YORK (USA)
Meeting legislative regulations and customer requirements for the manufacture and sale of medical devices in a global marketplace can be confusing. With so many regulations, differing from country to country, an organization must address a complex array of quality, process, and management issues in order to compete ...
Manufactured by:InBios International, Inc based inSeattle, WASHINGTON (USA)
We know that our success depends on your success. We work efficiently to meet the needs of our customers while abiding by our commitment to quality. ...
by:NSAI Inc. based inNashua, NEW HAMPSHIRE (USA)
ISO 13485 is a necessary certification for medical device manufacturers. It proves that you have a quality manufacturing process and the management standards in place to maintain high quality. ISO 13485 certification is the first step towards achieving compliance with European, Canadian and other regulatory requirements for medical device ...
Manufactured by:Lighthouse Imaging LLC based inWindham, MAINE (USA)
Lighthouse utilizes the phase/gate process that takes optical medical devices from concept through commercialization. We understand the importance of design control and risk management activities and incorporate these into our rigorous product development process. Lighthouse utilizes a traditional phase/gate process that takes medical devices from concept through commercialization. We understand ...
Manufactured by:BMC Medical Manufacturing S.A. de C.V. based inMonterrey, MEXICO
BMC Medical Manufacturing S.A. de C.V. provides sterilization services using ethylene oxide in a stainless steel chamber, complying with international standards (ISO 11135) and the safety measures required for your product, environmental and ...
by:STEMart based inShirley, CALIFORNIA (USA)
CE marking is the manufacturer's declaration that their product complies technically and administratively with the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and In Vitro Diagnostics Directive (IVDD) 98/79/EC, which outline the safety and performance ...