Navigation Links
Cohera Medical Receives ISO 13485 Certification: Company Meets International Standards for Design, Development and Manufacturing of Medical Devices
Date:9/22/2009

PITTSBURGH, Sept. 22 /PRNewswire/ -- Cohera Medical, Inc. announced today that it has received certification to the ISO 13485:2003 International Standard for the Design, Development, and Manufacture of Surgical Adhesives. Receipt of the certification allows Cohera Medical to proceed with the CE Mark registration and approval process for TissuGlu(R), the company's novel internal surgical adhesive, upon completion of development for its first indication to optimize healing and prevent fluid accumulation following abdominoplasty procedures.

The British Standards Institution issued the certification following an assessment and audit of the Company's quality management system and associated policies and procedures. The ISO 13485 certification is a required component of the CE Mark process for registration/approval of medical devices in the European Union.

"This certification represents a significant achievement and major milestone for an emerging company such as Cohera," said Patrick Daly, chief executive officer of Cohera Medical. "Successfully completing this process assists us in moving forward into clinical development of TissuGlu in the European Union."

Chad Coberly, vice president of clinical, regulatory and legal affairs said, "ISO certification validates that the design, development, and manufacturing systems Cohera has implemented will ensure the integrity of the devices we supply to the medical community worldwide. This means that Cohera is now well positioned as it progresses towards human clinical trials and ultimately applying for regulatory approvals for TissuGlu."

About ISO Certification

The International Organization for Standardization ("ISO") is a worldwide federation of national standards bodies. ISO 13485:2003 certification is an international standard that specifies a quality management system for the development, production and distribution of medical devices and related services.

About Cohera Medical

Cohera Medical, Inc. is a Pittsburgh, PA based company that is developing a revolutionary line of surgical adhesives. Cohera Medical's products are based on a unique chemical design that is purely synthetic, easy to use, biocompatible and fully resorbable. The company's lead product in development, TissuGlu, is an adhesive for plastic surgery procedures. TissuGlu adheres flaps of tissue after surgical procedures, eliminating the spaces where fluid accumulates and reducing wound drainage. Cohera Medical is also developing surgical adhesives targeting mesh fixation, small bone fixation, and other plastic surgery indications, which will fill similar market needs in plastic, orthopedic and general surgery. For more information, visit www.coheramed.com. TissuGlu and the other Cohera products are currently for investigational use only and have not yet been approved for medical use by the Food and Drug Administration (FDA) in the U.S. or in any other market.

Certain statements made throughout this press release that are not historical facts contain forward-looking statements regarding the Company's future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements.


'/>"/>
SOURCE Cohera Medical, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Data Published in Plastic and Reconstructive Surgery Show Cohera Medicals Surgical Adhesive, TissuGlu(R), Prevents Seroma Formation in Animal Abdominoplasty Model
2. Cohera Medical Names Richard L. Wonsettler as Companys First CFO
3. Cohera Medical Secures $16.1 Million in Series B Financing
4. MSU engineering team designs innovative medical device
5. ATS Medical to Present at the 2007 Thomas Weisel Partners Healthcare Conference
6. Providence St. Joseph Medical Center, Caregivers Reach Agreement on a Union Contract
7. Owner and Operator of Florida Durable Medical Equipment Company Convicted of Medicare Fraud
8. Father and Daughter From Tanzania Receive Their First Medical Examination in Newport Beach
9. Doctors and medical ethicist discuss whether doctors should participate in capital punishment
10. Preparation for Natural Disasters Critical for People With Diabetes, Chronic Medical Conditions
11. Doctors and Medical Ethicist Discuss Whether Doctors Should Participate in Capital Punishment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/26/2017)... ... April 26, 2017 , ... Intalere, the healthcare ... podcast, “Make Plans for MACRA,” highlighting the impact of the Medicare ... and how physicians and other clinicians are reimbursed for the care they deliver ...
(Date:4/26/2017)... ... April 26, 2017 , ... CareSet Labs today is releasing ... measured in Part D Medicare data. The dataset, called PaPR (Providers and Prescribing ... faxes or paper. The PaPR (pronounced "paper") data set aggregates this information ...
(Date:4/26/2017)... ... April 26, 2017 , ... The National Business Research Institute ... Registry of Emergency Medical Technicians and welcomes this organization to the NBRI ... G. West, Ph.D. , CEO & Organizational Psychologist at NBRI. “This award is ...
(Date:4/26/2017)... ... ... RawTrition now brings you BioEnergy which is a powder capsule whole food ... RawTrition is taking nutrients to the next level! The superfoods in RawTrition's BioEnergy ... (unlike the synthetically made options that are on the market). , Founder of RawTrition, ...
(Date:4/26/2017)... Doylestown, Pa. (PRWEB) , ... ... ... Solutions division, which provides an agile ecosystem and domain expertise for sponsors ... end-to-end, configurable randomization and trial supply management (RTSM) software platform. Bioclinica ...
Breaking Medicine News(10 mins):
(Date:4/24/2017)... UNION CITY, Calif. , April 24, 2017 /PRNewswire/ ... providing durability, grip, protection, and comfort, announces the release ... the Powerform S8+. This most recent example of leading ... high density grip pattern for 200% more tactile grip ... in user protection and durability. With TracTek and a ...
(Date:4/20/2017)... 20, 2017  Cogentix Medical, Inc. (NASDAQ: CGNT), ... the Urology, Uro/Gyn and Gynecology markets with innovative ... has joined the Company as Senior Vice President, ... position, Mr. Keswani will report directly to ... "Our organization is delighted that Ash has joined ...
(Date:4/20/2017)... DUBLIN , April 20, 2017 ... the "Global Biosimilar Pipeline and Market Prospects: Addressing ... report to their offering. ... "Global Biosimilar Pipeline and Market ... by Design" provides an in-depth assessment of the current ...
Breaking Medicine Technology: