medical device quality 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).

Active and Non-Active Medical Devices

When it comes to medical devices, quality and safety are especially vital. As a notified body, we can help you with your conformity assessment procedure and ensure that your active and non-active medical devices comply with EU Directive 93/42/EEC. Tap into the European ...

By TÜV Rheinland AG based in Köln, GERMANY.

Private Label (OEM) Services

We at Artron would like to work with you to build trust between you and your clients. We can provide your company with our products at a wholesale distribution price which you can then rebrand under your own private label, resting assured that you are offering your clients medical devices of the highest ...

By Artron Laboratories Inc. based in Burnaby, BRITISH COLUMBIA (CANADA).

Quality Services

We have met the demand to provide high quality medical devices and accessories. Not only do we have a first-class production process, but we also have flexible job management solutions, integrated management system and a client-friendly approach. The primary characteristic of our management policy is our ...

By A&G Ltd. based in Tallinn, ESTONIA.

The Medical Device Process Services

Our experienced team can help you develop a medical device from scratch or finish off a project. We can jump in at any of the following stages: Prototyping. If you can imagine it, we can help you bring your vision to life. Engineering. We create high-quality medical devices at a cost that makes sense. Sourcing. ...

By Medisurge based in Grand Rapids, MICHIGAN (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 primary ...

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

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).

Genmed - Research & Development Services

of delivering healthcare through our high-quality products and medical devices. We want to lead the way and create a path for others to follow and to achieve that, we focus on Research and ...

By Genmed Enterprises based in Cardiff, UNITED KINGDOM.

Assembly of Medical Components and Medical Supplies

Having a well-designed product is one of the key steps to manufacturing a fully functioning medical device, but if it is assembled poorly, or in the incorrect environment, the medical product design can only count for so ...

By Meridian Medical based in Littlehampton, UNITED KINGDOM.

Automation Services

is driving the MedTech industry. In fact, a recent MedTech Intelligence article showed that medical device manufacturers that had adopted automation in their production lines saw a 40-60% decrease in processing costs. This is why automation has become a much sought-after capability for medical device manufacturers. ...

By Quasar Medical Ltd. based in Hong Kong, CHINA.

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 Services

laws in various countries for medical device manufacturers, developers and service providers. Our quality organization is responsible for measuring the Group's processes and set quality objectives, acts as an advisor and applies for and manages marketing authorizations worldwide. An essential part of our ...

By Revenio Group Oyj based in Vantaa, FINLAND.

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).

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.

Atrion - Design & Engineering Services

Our engineering team is comprised of highly skilled and multifaceted individuals having the ability to think creatively and convert their novel ideas, concepts, and designs from functional prototypes to finished ...

By Atrion Corporation based in Allen, TEXAS (USA).

Design - Make - Ship - Deliver Services

Concept design, advanced engineering & electronics to final manufacture and supply, a total solution from design to manufacture – guaranteed. We provide advanced engineering to final manufacture with first-hand knowledge of quality manufacturing, a complete solution from start to ...

By ViVO Smart Medical Devices Ltd. based in Nottingham, UNITED KINGDOM.

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 Management Services

We understand that the components and devices we create are critical to health and well-being. So when we bring your medical device to life, we infuse stringent quality standards into every ...

By Tegra Medical based in Franklin, MASSACHUSETTS (USA).

Active Implantable Medical Devices

High-quality, active implantable medical devices, such as pacemakers or cochlear implants, give patients new quality of life. EU Directive 90/385/EEC defines the requirements for active implantable medical devices on the European market. As a notified body, we conduct conformity assessments for ...

By TÜV Rheinland AG based in Köln, GERMANY.

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).