Navigation Links
Rochester Medical Implants Achieves ISO 13485:2003 Certification for Medical Device Manufacturing
Date:9/25/2008

Certification Reflects Contract Manufacturing Company's Commitment to

High-Quality Standards and Stringent Compliance Guidelines

ROCHESTER, Ind., Sept. 25 /PRNewswire/ -- Rochester Medical Implants (http://www.rmi.us.com), a contract manufacturer of high-precision spinal and orthopaedic implants and instruments, announced today that it has achieved ISO 13485:2003 certification through auditor NSF International.

"Building upon our existing ISO 9001:2000 quality system, the ISO 13485:2003 certification process has been a major business initiative of our company and reflects the organization's commitment to manufacturing high-quality products for the medical device market," commented James K. Evans, President of Rochester Medical Implants. "Achieving this important objective sets RMI apart from many of our competitors and offers our customers a quality partner able to help them achieve their business initiatives."

Rochester Medical Implants, located in Rochester, Indiana, is a team of medical device manufacturing professionals bringing expertise to the entire product realization process. Whether working with customers to launch new technologies or improve existing devices, RMI innovates manufacturing processes that allow for improved quality and superior time to market. The company's core competencies include fully integrated services in CAD/CAM engineering, 5-axis CNC milling, turning and wire EDM, process development, material sourcing, laser marking, assembly and packaging.

ISO 13485:2003 applies to organizations involved with the product design, engineering and contract manufacturing services for medical device customers. The RMI facility, which includes a dedicated isolation room for the fabrication of implant grade PEEK-Optima products, can accommodate manufacturing, assembly and packaging of a wide variety of medical devices. The ISO certification process ensures ongoing compliance as companies are externally audited every twelve months.

RMI's quality policy says it all, "Critical products manufactured to the highest quality standards, first time, every time!"

Rochester Medical Implants serves as a subcontract manufacturer for large OEM suppliers of surgical orthopaedic products, as well as custom design houses working with leading orthopaedic surgical groups developing innovative implants and instruments. Many of our customers do not have in-house manufacturing capability and rely exclusively on RMI to prove out concepts, develop prototypes, provide assistance with design for manufacturability (DFM), and satisfy their production needs with short lead times. RMI is an SBA Certified HUBZone firm and maintains FDA registration for customer products.

Rochester Medical Implants is located in Rochester, Indiana. For more information visit http://www.rmi.us.com, email us at info@rmi.us.com, or call 574.223.8198.

This release was issued through eReleases(TM). For more information, visit http://www.ereleases.com.


'/>"/>
SOURCE Rochester Medical Implants
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. U.S. Reps. Oberstar and Walz Discuss DM&E Railroad Expansion With Rochester, Minn. Leaders
2. Rochester Medical Reports Record Fourth Quarter Sales and Record Year
3. Rochester Medical Announces First Quarter 2008 Earnings Conference Call February 4, 2008
4. Mayo Clinic Seeks Mitigation for Rochester as Condition of Canadian Pacific - DM&E Railroad Merger
5. Rochester Medical Applauds Improved U.S. Medicare Coverage Policy for Intermittent Catheters
6. Rochester Medical Marketing VP Retires
7. Rochester Coalition and Mayo Clinic Challenge Railroads Contention That Hazmat Rail Shipments Pose no Risk
8. Rochester Medical Honored by Premier Healthcare Alliance for Exceeding Performance Expectations
9. Autovan Donates Wheelchair-Accessible Van; Brings Greater Mobility to Facility in Rochester, New York
10. MSU engineering team designs innovative medical device
11. ATS Medical to Present at the 2007 Thomas Weisel Partners Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... ... The Visiting Nurse Association (VNA) of Somerset Hills is proud to host ... items from across the nation, this holiday-themed event will raise funds and awareness for ... The boutique will be open Saturday, November 4 (10:00 a.m. – 5:00 p.m.) ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, ... lowdown on sciatica in a new episode of "Success Files," which is an ... and innovation and investigates each subject in-depth with passion and integrity. , Sciatica ...
(Date:10/12/2017)... ... 12, 2017 , ... First Healthcare Compliance (FHC), an industry ... a range of technology and learning solutions at the 68th Annual American Healthcare ... be held October 14–18, 2017 at the Mandalay Bay Resort in Las Vegas, ...
(Date:10/12/2017)... CITY, Fla. (PRWEB) , ... October 12, 2017 , ... ... cold therapy products, announced today the introduction of an innovative new design of the ... multipurpose pad so you get maximum comfort while controlling your pain while using cold ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... has recently contributed a medical article to the newly revamped Cosmetic Town ... article spotlights the hair transplant procedure known as Follicular Unit Extraction ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... , Oct. 12, 2017 AVACEN Medical , ... company with their  2017 New Product Innovation Award for ... extensive primary and secondary medical device market research by Frost ... its first-to-market OTC, drug-free pain relief product, the AVACEN 100, ... to treating fibromyalgia widespread pain. ...
(Date:10/11/2017)... Texas , Oct. 11, 2017  True ... services, has amplified its effort during National Breast ... about hereditary cancer risks. ... of Clinical Oncology calculated that more than 10 ... have inherited mutations in BRCA1 or BRCA2 and have ...
(Date:10/5/2017)... , Oct. 5, 2017  In response ... of Oral and Maxillofacial Surgeons (AAOMS) released prescribing ... – to be used as a first-line therapy ... Recognizing the ... AAOMS White Paper "Opioid Prescribing: Acute and Postoperative ...
Breaking Medicine Technology: