medical implant Services

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.

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 in place ...

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

Precision Machining Service

Micron Solutions has many years of experience machining complex components to the tightest tolerances for medical implants and mission critical defense applications. We have a full array of machining services available, including CNC milling, Mill/Turning and ...

By Micron Solutions based in Fitchburg, MASSACHUSETTS (USA).

Research & Development Services

Here at spinesmith, we understand that medical implants can't just be metal and plastic. They need to be fully integrated biological systems, which means that engineers need to take into account the material and physiological properties of both the implant and the system it needs to improve. ...

By Spinesmith Holdings, LLC based in Austin, TEXAS (USA).

Fatigue and Force Testing Services

We do our testing in-house and regularly use the following equipment to characterize materials and validate medical implant designs: Bose 3230 Fatigue Test System. Mark-10 Quasi-static Load Frame. High Speed Rotary Bend Wire Testing. High Speed Rotary Bend Stent Testing. Stent Radial Force Characterization. ...

By Echobio LLC based in Bainbridge Island, WASHINGTON (USA).

Engineering Service

We specialize in consulting on the engineering design of plastic products/components, molding tools, and medical implants. We work with both 3D and 2D models in almost any modern CAD/CAM/CAE engineering software package. ...

By Micron Solutions based in Fitchburg, MASSACHUSETTS (USA).

Design & Development Services

With over 35 years experience and with product certifications in over 70 countries, Oscor is the industry leader in the design and development of minimally invasive and implantable medical ...

By OSCOR Inc. based in Palm Harbor, FLORIDA (USA).

Histopathology Services

NAMSA’s provides advanced histological technology for the testing and evaluation of implanted medical devices. Valuable tissues can be collected and processed on-site under the supervision of a board certified pathologist. Histopathology services are also provided on fixed tissues from outside ...

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

UroMems` Solution

UroMems’s ambition is to revolutionize the treatment for severe urinary incontinence using the latest technological advances in the field of embedded systems and micro-technologies for the development of its implantable ...

By UroMems based in Grenoble, FRANCE.

ProStart - Change Management Program Services

ProStart is a change management program designed for a seamless transition to a complete Stryker Trauma & Extremities ...

By Stryker Emergency Care based in Kalamazoo, MICHIGAN (USA).

Titanium Shearing Services

Because it is one of the most resilient metals in the world, cutting titanium is no easy task. The process of cutting titanium sheet is made even more complicated by the material’s reactivity to heat. That means it’s not possible to cut titanium using traditional methods without changing its chemical composition. As an industry leader, Titanium Processing Center is highly experienced ...

By Titanium Processing Center (TPC) based in New Baltimore, MICHIGAN (USA). from Titanium Services 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

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.

Electropolishing Service

Since 1954, Able Electropolishing has been providing metal finishing services to a variety of industries. Now our electropolishing service is suitable for a wider variety of alloys, providing a number of benefits that make parts last longer, perform better and maintain a clean, like-new appearance. ...

By Able Electropolishing based in Chicago, ILLINOIS (USA).

CE Certification

CE Marking is the symbol as shown on the top of this page. The letters 'CE' are the abbreviation of the French phrase 'Conformité Européene' which literally means 'European Conformity'. The term initially used was 'EC Mark' and it was officially replaced by 'CE Marking' in the Directive 93/68/EEC in 1993. 'CE Marking' is now used in all EU official ...

By SustChem Engineering S.A. based in Athens, GREECE. from Certification Services Service line

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 device ...

By Management Systems Solutions based in Ambala City, INDIA.

EMI - Electromagnetic Interference (EMI) Testing Consultant Services

Boston Scientific adheres to the Association for the Advancement of Medical Instrumentation (AAMI) standards for testing of implantable pacemakers, implantable cardioverter defibrillators (ICD), or heart failure devices (cardiac resynchronization therapy-defibrillator [CRT-D] or -pacemaker [CRT-P]) in the ...

By IAQ-EMF CONSULTING INC. based in Boynton Beach, FLORIDA (USA).

Audits Services

An audit is the most effective method to establish certainty that you as the manufacturer or distributor of medical devices are in the position to meet all requirements. Metecon offers comprehensive support in this regard with a wealth of experience and know-how. Take a moment to get an overview of our ...

By Metecon GmbH based in Mannheim, GERMANY. from Services IVD - Quality Management Service line

Implantable Drug Delivery

Precision Drug Therapies: Often designed as active implants, these devices are increasingly helping to treat chronic pain, cancer, diabetes and other conditions. Typical designs comprise a reservoir for medication, a battery-powered pump programmed to release the medication at prescribed dosages and ...

By Cirtec Medical based in Brooklyn Park, MINNESOTA (USA).