medical device development Services

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.

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

Medical Device Development and Design Services

At in2being, we specialize in helping both businesses and individuals navigate medical device development and design within the regulatory landscape in the most efficient way possible. in2being’s skilled med-tech professionals are the catalyst that brings customer ideas to life while achieving ...

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

Agile Medical Device Software Development Services

Drastically Reduce Time to Market & Adapt to Change Faster Than Your Competitors. Orthogonal applies Agile software development methods to medical device software development, allowing us to move faster while still delivering the quality, safety and reliability your device ...

By Orthogonal based in Chicago, ILLINOIS (USA).

STEMart - Pilot Production Services of Medical Devices

Processes close or equal to those to be used in production. Pilot production is a crucial process for devices that will be tested in clinical trials or pilot markets before transitioning to full-scale production. If the customer’s medical device is successful in a pilot market or clinical trial, it will ...

By STEMart based in Shirley, CALIFORNIA (USA). from Medical Device Development Service Service line

Medical Device Prototyping Services

. Non-functional prototypes are used to provide people with a non-digital representation of the product. When it comes to medical device prototyping, a functional prototype is not one that can be used in the market—it is not a final product, but a functioning example that can be used to develop a better ...

By STEMart based in Shirley, CALIFORNIA (USA). from Medical Device Development Service Service line

STEMart - Medical Device Design Services

Medical device design is a complex sphere that includes creation and development of effective and life-improving tools and technologies aimed at reducing life risks and helping with medical equipment enhancement. Medical devices design is an important specific of product design, since numerous ...

By STEMart based in Shirley, CALIFORNIA (USA). from Medical Device Development Service Service line

Cytotoxicity Testing Services

Cytotoxicity testing is a sensitive method to assess the biocompatibility of a material extracted through a specific cell culture media following exposure of the extracted fluid to L929 cells. This test is performed on raw materials in the manufacturing process, all medical devices contacting patients, and ...

By STEMart based in Shirley, CALIFORNIA (USA). from Medical Device Development Service - Medical Device Testing Service line

Cleaning Validation Services

Cleaning is defined as removal of soil residues with manual or automated method. It is always the first and necessary step in reprocessing of reusable medical device. ...

By STEMart based in Shirley, CALIFORNIA (USA). from Medical Device Development Service - Reusable Medical Device Validation Service line

STEMart - Hip Joint Prostheses Testing Service

STEMart performs a variety of testing for partial and total hip joint prostheses to measure how they will withstand different levels of fatigue, compression, torsion, and bending over an extended period of time. ...

By STEMart based in Shirley, CALIFORNIA (USA). from Medical Device Development Service - Implantable Medical Device Testing Service line

STEMart - Active Implantable Medical Device Testing Service

An active implantable medical device (AIMD) is any active medical device that is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice for diagnostic or therapeutic purposes, and which is intended to remain ...

By STEMart based in Shirley, CALIFORNIA (USA). from Medical Device Development Service - Implantable Medical Device Testing 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

Diagnostics Development Services

Next generation electrochemical platform development, enabled by Gii-Sens. Our assay development service produces rapid diagnostics systems that enhance end-user experience, deliver accurate results and improve diagnosis turnaround times. As experts in advanced material technologies and medical device development ...

By Integrated Graphene Ltd, based in Stirling, UNITED KINGDOM.

Multidisciplinary Engineering Services

NextPhase has developed a strong, team-oriented, multidisciplinary engineering group. Our engineers average more than a dozen years of experience in the medical device development and manufacturing arena. ...

By NextPhase Medical Devices LLC. based in Mansfield, MYANMAR.

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 ...

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

Services for Innovators

The MediPurpose™ Medical Device Innovation division collaborates with medical device inventors and innovators to take new medical devices from concept to commercialization—bringing together financing, proven medical device development ...

By MediPurpose based in Duluth, GEORGIA (US) (USA).

Molecular Diagnostic Services for Research and Clinical Trials

Norgen Biotek is accredited to ISO 15189:2012, emphasizing our commitment to quality in our laboratory and R&D services. Norgen offers a number of laboratory services to the scientific community and for medical device developers and manufacturers including highly competent molecular diagnostic testing for ...

By Norgen Biotek Corp. based in Thorold, ONTARIO (CANADA).

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.

Biosensor & Medical Diagnostic Services

We are uniquely placed to help you change the future of point of care testing. By combining the medical device design and development expertise of our design engineering team and our advanced materials expertise, we deliver seamless graphene biosensor development and manufacturing services that enables our ...

By Integrated Graphene Ltd, based in Stirling, UNITED KINGDOM.

Aftermarket Services

The NextPhase team is committed to partnering with customers throughout the product lifecycle. Our value-added services extend beyond medical device design, development, and manufacturing to support an array of mechanical and software-driven electromechanical devices. Aftermarket services is another example of how ...

By NextPhase Medical Devices LLC. based in Mansfield, MYANMAR.