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Iso 13485 Certification Services
17 services found
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 ...
by:Neuromod Devices Limited based inDublin, IRELAND
Neuromod maintains a certified Quality Management System to ensure compliance to the applicable regulations in regions that it distributes its devices. Neuromod’s Quality System Certificate ISO 13485: 2016. Neuromod’s CE Certificate Full Quality Assurance. ...
Manufactured by:Delmont Imaging based inParis, FRANCE
Delmont imaging has since day one, focused on delivering highest quality products with full CE certification (MDD 93/42) and good manufacturing practice certification ISO 13485:2016. Our products are now registered in more that 50 countries across the world and this number is continuously growing. ...
Manufactured by:Meridian Medical based inLittlehampton, UNITED KINGDOM
From design, your product moves to the medical product development stage to determine whether it is fit for the purpose or purposes you are developing the product ...
by:SCREENTEC based inOulu, FINLAND
Our ISO 13485 and certification supports our growth as a contact manufacturer of medical devices and ...
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 ...
Manufactured by:Tristel Solutions Ltd. based inSnailwell, UNITED KINGDOM
Tristel maintains a single Quality Management System conforming to BS EN ISO 13485:2016, as the minimum standard for medical devices to ensure the maintenance of regulatory requirements, and BS EN ISO 9001:2015 for non-medical products to ensure continual improvement to achieve customer satisfaction. The principles and guidelines of GMP are implemented in the facility with reference to Rules and ...
Manufactured by:Weber Instrumente based inmmingen-Liptingen, GERMANY
Full-service provider of surgical instruments. All from one source: We offer you the complete service package, from the original idea right through to series production, and prepare the necessary documentation. 30 years of experience make Weber Instrumente a reliable and versatile partner for your new ...
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. ...
Manufactured by:CardiacSense based inCaesarea, ISRAEL
CardiacSense Is Watching Over You. The CardiacSense watch is a clinically proven medical device that delivers reliable cardiac and blood pressure monitoring, 24/7/365, for as long as needed. Simple to use, the CardiacSense wearable is worn on the wrist just like a regular watch. There are no wires, cables, or connections. It’s completely noninvasive. But behind the watch face lies a ...
Manufactured by:Lighthouse Imaging LLC based inWindham, MAINE (USA)
We understand the importance of design control and risk management activities and incorporate these into our rigorous product development process. Our ISO 13485:2016 certification is a testament to this rigor and our commitment to product development ...
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 ...
Manufactured by:Avania based inBrunswick, AUSTRALIA
All businesses are unique - consistency and reliability are critical to ensuring quality. Whether you are part of an emerging company or a long-established multinational corporation, Avania can ensure your quality system fits your organizational ...
Manufactured by:Bastos Viegas, SA based inGuilhufe, PORTUGAL
Bastos Viegas SA always had and still has as one of its main objectives produce high quality and meeting the requirements of its customers and the market in general as well as all applicable legal requirements. Therefore Bastos Viegas bet on the implementation and constant updating of a quality control system that currently has decades of experience. In this sense always equipped its laboratories ...
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 ...