medical device Services

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CE Marking for Medical Devices

and user safety, as well as the performance of the device. BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Services Service line

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).

Medical Devices

Mastermelt Metal Management provides refining services for the medical device industry. We refine guide wires, marker bands, rags, wipes, anti-bacterial silver products, gold coated products. Pt, Pt10Ir, Pt20Ir, Pt10Ni, gold and palladium are our ...

By MASTERMELT METAL MANAGEMENT based in Sweetwater, TENNESSEE (USA).

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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

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).

Medical Device Service

WaveClear Vascular medical device services were established to meet the need for treatment technologies to combat vascular diseases. We leverage the unique properties of ultrasonic energy and its effects to dissolve blood clots in peripheral ...

By WaveClear, Inc. based in Erie, PENNSYLVANIA (USA).

Medical Device Testing

Microbac understands the new challenges facing biomedical companies as the industry undergoes rapid change and the introduction of radical new device designs, biomaterials, and testing techniques. Our staff focuses on working with you to develop a medic device testing regime that will assist in turning your ...

By Microbac Laboratories, Inc. based in Pittsburgh, PENNSYLVANIA (USA). from Testing Services - Antimicrobial Efficacy Testing Service line

Pharmaceutical & Medical Devices

Atlanta-based MVA Scientific Consultants provides analytical testing services to the pharmaceutical and medical device industries. We have a reputation for high quality services and data integrity and we will stand behind our work in the event of ...

By MVA Scientific Consultants based in Duluth, GEORGIA (US) (USA).

Medical Device Testing

Pace Analytical Life Sciences, LLC provides industry-standard methods and custom analytical chemistry and microbiology services for the testing of medical devices. Our service offerings for the medical device industry are based on industry standards and follow the guidance of ISO, AAMI, ANSI, and ASTM ...

By Pace Analytical based in Minneapolis, MINNESOTA (USA).

Validation of Medical Devices Services

Medical devices demand the highest degree of safety, functionality and efficiency. A well planned and performed validation program is the basis for a safe and efficient product and a successful product approval. puracon can support you not only in setting up a product-based validation program, but also in ...

By Puracon GmbH based in Rosenheim, GERMANY.

Formative Testing of Medical Devices

Whether a product is really good can only be seen when it comes into contact with the subsequent user. The time of the first contact is decisive for the quality of your ...

By Custom Medical based in Darmstadt, GERMANY.

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 your active ...

By TÜV Rheinland AG based in Köln, GERMANY.

Medical Device Development Services

We transform innovative ideas into a commercial reality.Our multidisciplinary team combines design knowledge, engineering expertise, and problem-solving skills to create innovative design ...

By Integrated Technologies Ltd. based in Ashford, UNITED KINGDOM.

Packaging of Medical Devices Services

Imagine you could reduce the lead time of your packaging solution from many months to 6 weeks while still saving money. That’s what we can offer you with our new pre-validated packaging. Our packaging concept for medical devices is flexible for a variety of products, it is easy to use and combines ...

By Puracon GmbH based in Rosenheim, GERMANY.

Medical Device Regulation Services

The Food and Drug Administration (FDA) regulates all medical devices in the United States to make sure they are safe and effective. These regulations are a critical part of the medical device development process, and they will likely influence the design and testing of new medical devices. ...

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

Medical Device Development Services

Minimally invasive therapeutic and diagnostic medical products for: Electrophysiology cardiology, radiology, cryotherapy, drug delivery, pulmonology, gastroenterology, pain management, neurology. Catheter-orientated manufacturing process development. Supply chain selection, management, and technical oversight. ...

By Resonetics based in Nashua, NEW HAMPSHIRE (USA). from Agile Product Development Service line

Logistics of Medical Devices Services

Outsourcing your warehouse and logistics for your medical devices to puracon, allows you to focus on the really important tasks in your company such as R & D, regulatory, manufacturing and selling. At the same time, you can rest assured that your medical products arrive at your customers quickly, safely, ...

By Puracon GmbH based in Rosenheim, GERMANY.

Medical Device Design Services

We create solutions to complex design and engineering challenges. Our medical device design services help customers accelerate time to market cost-effectively while minimizing ...

By Integrated Technologies Ltd. based in Ashford, UNITED KINGDOM.

Summative Testing of Medical Devices

This is the performance measure for the product and the official proof that the product is safe to use. This requires that acceptance criteria (What must the product be able to do? How safe must it be?) be jointly defined by you as the manufacturer and us, and tested in the test with the users ...

By Custom Medical based in Darmstadt, GERMANY.

Medical Device Packaging Service

When looking for the right medical product packaging, it’s important to find a company that considers the specificity of your needs. Mi3 offers specialist medical device packaging as a standalone contract packaging service or as part of a wider medical product design and development project. The team at ...

By Mi3 Limited based in Lancashire, UNITED KINGDOM.