medical device production 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

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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

Service

in the process of medical device production – thanks to this, our service staff can match world standards and best practices. For many years, we have provided Polish and foreign companies with comprehensive service, which helps our Clients perform their ...

By Famed Zywiec Sp. z o.o. based in Zywiec, POLAND.

GENESIS Tech Center Services

Tegra Medical’s GENESIS Tech Center® services include prototyping, development, and pilot production, so you can focus on designing and selling your medical devices. These product-launching services are the first step of our true end-to-end manufacturing solutions, working in concert with ...

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

Non-Clinical Testing Services

NAMSA’s balance of trusted advisors and proven process lets us support clients across the entire medical device product development spectrum.Non-clinical studies are used to select prototypes and provide an understanding of device performance in a specific application. When it comes to non-clinical testing, ...

By North American Science Associates Inc.(NAMSA ) based in Northwood, OHIO (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.

OEM Full Service

WOM represents innovation in Minimally Invasive Medicine. Accordingly, our teams stand out when it comes to the assembly of medical devices and cleanroom production due to their vast amount of ...

By W.O.M. World of Medicine GmbH based in Berlin, GERMANY.

Test Strategy Services

Getting there quickly with the right test strategy; Verification proves that your product was developed and built correctly and is thus an essential part of the development of each medical device. Based on your product specification, we develop the optimum test strategy by means of which we achieve full test ...

By Metecon GmbH based in Mannheim, GERMANY. from Services Medical Devices - Verification and Validation Service line

Quality Manufacturing Services

As an FDA-registered and ISO 13485:2016 certified medical device manufacturer, we manufacture products that meet all specifications and relevant regulatory requirements. Thanks to rigorous quality management throughout our manufacturing process, we build medical products that work as intended time and time ...

By Domico Med-Device based in Fenton, MICHIGAN (USA).

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.

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).

Sterigenics - Expert Advisory Services

From product conception to commercialization, each stage in the life cycle of a medical device, pharmaceutical, or commercial product can be extremely challenging. Since there are many considerations when sterilization is the required outcome, it’s best to collaborate with an Expert Advisor to ensure your ...

By Sterigenics U.S., LLC based in Oak Brook, ILLINOIS (USA).

Product Recall Services

A product recall or withdrawal is a source of great anxiety for any manufacturer. Fortunately, Stericycle’s ExpertRECALL can help restore your peace of mind and protect your brand. Whether you are a pharmaceutical, medical device or consumer product manufacturer or retailer, we can handle every aspect of ...

By Stericycle, Inc. based in Lake Forest, ILLINOIS (USA). from ExpertSOLUTIONS Services Service line

Build Services

, and quality requirements: Professional digital health services to create and/or implement your digital health solution on the BrightInsight Platform, including apps, algorithms, medical devices, connected combination products, diagnostics, and Software as a Medical Device (SaMD), Data integration and management ...

By BrightInsight, Inc based in San Jose, CALIFORNIA (USA). from Digital Health Services Service line

Medical Device Regulation Compliance Services

Medical Devices and In Vitro Diagnostics Product Regulatory Compliance in China. Pre-market Investigation & Analysis. Medical Devices Registration & Approval. Clinical Trial Consulting. Manufacturing and Distributing License Approval. Quality Assurance & Compliance. Risk Assessment & ...

By Chemical Inspection & Regulation Service Limited (CIRS) based in Hangzhou, CHINA.

Consulting Engineering Services

Process, Product & Package Development. Manufacturing/Packaging Line Design. Auditing Quality, Safety Procedures. Compliance Monitoring- Federal Regulations. Medical and Technical Writing. Food Products, Pharmaceuticals, Medical Devices, Cosmetics & Veterinary Products. Training of ...

By Conatech Consulting Group, Inc. based in Creve Coeur, MISSOURI (USA).

Charles - Safety Assessment Services

From complete IND-enabling programs to stand-alone assessments, our Safety Assessment team provides a full range of in vivo and in vitro testing services and regulatory support to comply with worldwide regulatory restrictions for the nonclinical development of pharmaceuticals, medical devices and animal ...

By Charles River based in Hollister, CALIFORNIA (USA). from Products & Services Service line

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.

Design Services

the product to your expectations. Taking into account functional and useful requirements, and following the guidelines in medical device standards, we give the product its final shape. The selection of materials takes place in consultation with you at the same time meeting the REACH and RoHS ...

By SORIMEX sp. z o.o. sp. k. based in Torun, POLAND.

Intellectual Property Services

broad experience allows us to provide these services for a wide range of products in the petrochemical, manufacturing, medical devices, automotive, aerospace, offshore, marine and rail market ...

By KnightHawk Engineering, Inc. based in Houston, TEXAS (USA). from Legal Support Services Service line