medical device quality management Services

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).

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 ...

By Sustain Edge based in Chesterfield, MONTANA (USA). from Management Systems Service line

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).

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).

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).

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.

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).

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).

Quality Services

Our ISO 13485 and certification supports our growth as a contact manufacturer of medical devices and ...

By SCREENTEC based in Oulu, FINLAND.

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.

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.

ISO 13485:2003 (Quality Management System – Medical Devices) Services

Certification of quality management system, specifically for medical devices to ISO 13485: 2003 will help the organizations to market their products and also to improve the efficiency of the organization. ISO 13485 Certification is one of the most recognized and respected in the global medical ...

By Management Systems Solutions based in Ambala City, INDIA.

Audits Services

An audit is the most effective method to establish certainty that you as the manufacturer or distributor of medical devices are in the position to meet all requirements. Metecon offers comprehensive support in this regard with a wealth of experience and know-how. Take a moment to get an overview of our ...

By Metecon GmbH based in Mannheim, GERMANY. from Services IVD - Quality Management Service line

ISO Medical Device Standards Services

Medical devices are powerful and essential tools in the healthcare industry. Because they come in direct contact with patients and can have an effect on them, ensuring they meet safety standards is a critical part of the development and manufacturing ...

By in2being, LLC based in Saline, MICHIGAN (USA).

Regulatory and Quality Consulting for Device and IVD Companies

It is easy to make mistakes in the regulatory process that can delay market entry or incur unnecessary costs. With help from Emergo’s medical device RA/QA consultants, you can pursue the most efficient regulatory route to approval and registration for your device, and maintain compliance with ...

By Emergo by UL based in Austin, TEXAS (USA). from Medical Device Market Access Consulting Service line

STEMart - Notified Body (EU) Services

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 ...

By STEMart based in Shirley, CALIFORNIA (USA). from Medical Device Development Service - Medical Device Certification Services Service line