medical device management services
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ISO 13485 Medical Devices Management System
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary ...
By Sustain Edge based in Chesterfield, MONTANA (USA). from Management Systems Service line
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ISO 13485 Medical Device Manufacturing System Quality Management Certification from NSAI
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 NSAI Inc. based in Nashua, NEW HAMPSHIRE (USA).
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Premium
BSI VerifEye - Compliance Navigator
BSI Compliance Navigator is the smart, simple way to manage your regulatory information for Medical Device and In Vitro Diagnostic products with EU, UK and US requirements – helping you to get to market faster and maximize your ...
By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Services Service line
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Security Services
Medical device flow management requires heavy means and procedures to ensure traceability, quality and product integrity, due to the sensitivity of their nature and ...
By IMPLANET based in Martillac, FRANCE.
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Quality Services
management system fulfills the requirements of the European Medical Devices Directive 93/42/EEC Annex II on medical devices as well as other national and legal guidelines and standards, such as QSR of the US FDA. In doing so, we want to ensure that the manufactured products meet a level that our customers around ...
By GEOMED Medizin-Technik GmbH & Co. KG based in Tuttlingen, GERMANY.
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Quality Services
HIPAA compliant data management. ISO 13485:2016 quality management system. Class II Medical Device: FDA 510(k) ...
By Circadia Health based in PENNSYLVANIA (USA).
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POC Diagnostic Product Manufacturing Services
Lumos has a world-class ISO 13485 certified OEM manufacturing facility, co-located with its technical R&D team to reduce the time and risk of transfer into production, and for ongoing ...
By Lumos Diagnostics based in Sarasota, FLORIDA (USA).
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Product Development Services
Nordson MEDICAL provides elegant and robust design and development solutions of finished medical ...
By Nordson Medical based in Minneapolis, MINNESOTA (USA).
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Quality Management System Implementation Consulting Services (QMS)
These International Standards specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to consistently provide products that meets customer and applicable regulatory requirements, and aims to enhance customer satisfaction through the effective ...
By Lean ISO Experts, Inc. - Green and Sustainable Solutions, Inc. based in Hollywood, FLORIDA (USA).
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Design, Development and Prototyping Services
In order to identify and address design and engineering flaws in the early stage, we use rapid prototyping technology with 3D printers. The main benefit of this method is quick and cost-effective prototype development, enabling us to identify any deficiencies in the design during the product development phase. In this way, new potential solutions are generated. By selecting the optimal solutions, ...
By Eonex d.o.o. based in Trnovec Bartolovecki, CROATIA.
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Clinical Research & Regulatory Support Service
As a full contract research organization (CRO), Toolbox provides the fastest path to FDA clearance for your IVD diagnostic device study. Our team has achieved multiple dual and straight 510(k) and CLIA Waiver submission clearances and we can do the same for your medical ...
By Toolbox Medical Innovations based in Carlsbad, CALIFORNIA (USA).
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Quality Assurance Services
At Exact Medical, we treat every project with the same unwavering commitment to quality. Our systematic approach to quality assurance gives Exact Medical the confidence that every step - from material sourcing, validation, production and packaging to delivery - is precise and achieves our customers’ ...
By Exact Medical Manufacturing, Inc. based in Lancaster, NEW YORK (USA).
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Medical Devices
LEGEND"s Investigative Chemistry Department specializes in supporting the unique analytical chemistry and physical testing needs associated with medical device manufacturing and product development. Experienced chemists manage routine quality control analyses as well as customized developemental and validation ...
By Legend Technical Services, Inc. based in Phoenix, ARIZONA (USA).
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Quality Services
Our ISO 13485 and certification supports our growth as a contact manufacturer of medical devices and ...
By SCREENTEC based in Oulu, FINLAND.
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Services for Innovators
The MediPurpose™ Medical Device Innovation division collaborates with medical device inventors and innovators to take new medical devices from concept to commercialization—bringing together financing, proven medical device development methodology and ...
By MediPurpose based in Duluth, GEORGIA (US) (USA).
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ISO 13485
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 ...
By Bureau Veritas Certification North America based in BUFFALO, NEW YORK (USA). from Quality Management Systems Service line
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Manufacturing Services
Advanced Engineering and Total Quality Management for the manufacture of medical devices and healthcare products. We provide trusted OEM Quality Manufacturing Services that complies with ISO13485 specifically meeting the needs of the healthcare ...
By ViVO Smart Medical Devices Ltd. based in Nottingham, UNITED KINGDOM.
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ISO 13485 Medical Device/ Pharmaceutical Certification Service
of medical devices. While compatible with the quality management standard ISO 9001, ISO 13485 requires proof of implementation and maintenance, but not continuous improvement. ...
By Smithers Quality Assessments, Inc. (SQA) based in Akron, OHIO (USA).
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Medical Devices Services
In the highly competitive medical device industry, manufacturers must ensure they meet stringent regulatory requirements while providing the highest quality product or service that is cost ...
By EAGLE Certification Group based in Dayton, OHIO (USA).
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Regulatory Services
development consulting services help biopharmaceutical and medical device companies shorten time to market, manage risk, access new global markets, and leverage the latest technology to maximize portfolio ...
By Omega PharmServices, Inc. based in Whitinsville, MASSACHUSETTS (USA).
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