medical device certification Services

ISO 13485 Medical Device/ Pharmaceutical Certification Service

You need a trusted auditor for your (Medical Device/ Pharmaceutical) certification. Choose Smithers Quality Assessments (SQA) for personal, expert assessment services, tailored to your business needs. ISO 13485 was established in 2003 as an international standard for the design, manufacture and ...

By Smithers Quality Assessments, Inc. (SQA) based in Akron, OHIO (USA).

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

Kelmac Group - ISO 13485 Certification - Shared Work Approach Services

Kelmac Group’s Shared Work Approach for achieving ISO 13485 Certification is a perfect option for small-medium sized businesses that want to play a significant role in the project and keep consulting costs to a minimum.ive ...

By Kelmac I Group, Inc based in Chicago, ILLINOIS (USA). from Consulting - Medical Devices Consulting - ISO 13485 Certification Service line

Quality Services

The medical devices we make have the potential to change patients’ lives. We take that responsibility very seriously. That’s why we’re ISO 13485:2016 certified and FDA Registered. We also hold a Japan Foreign Medical Device Manufacturing certificate. With MediSurge, you know your ...

By Medisurge based in Grand Rapids, MICHIGAN (USA).

Quality Service

Quality Keeping You And Your Customers Satisfied. Well trained employees and established process controls ensure consistent product quality. Your customer satisfaction is based on our steady product quality and delivery reliability. MHMedical Tec designs, manufactures and sells medical devices. Our ...

By MHMedical Tec GmbH based in Großostheim, GERMANY.

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

InBios Contract Manufacturing Services

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 InBios International, Inc based in Seattle, WASHINGTON (USA).

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).

Chamber Manufacture and Transportation Services

The OxyHelp Hyperbaric Oxygen Therapy Capsules are built to the highest standards of design and engineering to deliver top-of-the-line products to clients worldwide ...

By OxyHelp Industry GmbH based in Köln (Cologne), GERMANY.

Design & Manufacturing Services for Unmet Needs

From clinical demands to product distribution, a medical device contains different elements, including demand clarification, prototyping, tooling, regulatory certification, trail production, etc. We realize that there are many discovered unmet needs in the medical device market that can bring out better ...

By Shining World Health Care Co., Ltd. based in New Taipei City, TAIWAN.

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.

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).