medical device management system Services

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 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).

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 ...

By GEOMED Medizin-Technik GmbH & Co. KG based in Tuttlingen, GERMANY.

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).

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).

Quality Services

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

By SCREENTEC based in Oulu, FINLAND.

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

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).

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

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