iso 13485 Latest News

Recertification Validates MediPurpose’s Medical Product Quality Management System (QMS)

Renewal Validates Company's Medical Device Development Quality Management System and Enables CE Marking for EU Medical Product Sales

Global Pacific Manufacturing Group LLC (www.gpacmfg.com ) has developed an ISO 13485 FDA QSR Compliant Quality Management System

Kubtec receives certifications for ISO 9001 and 13485 quality management systems

This 90-minute webinar will help you understand the competence and training requirements in the Quality Management Systems for medical devices, especially FDA QSR, ISO 13485, and even ISO 9001.

TNMC Medical Devices (Andre ten Napel) assisted Beier Drawtex Healthcare to obtain ISO 13485 and MDD 93/42/EEC Annex II Certification for its wound dressing

Inteprod, Medical Contract Manufacturer, cited for its role as Contract...

Recertification Validates MediPurpose’s Medical Product Quality Management System (QMS)

Renewal Validates Company's Medical Device Development Quality Management System and Enables CE Marking for EU Medical Product Sales

Global Pacific Manufacturing Group LLC (www.gpacmfg.com ) has developed an ISO 13485 FDA QSR Compliant Quality Management System

Pennsylvania Medical Contract Manufacturer Supports Nationwide Celebration of Manufacturing

Kubtec receives certifications for ISO 9001 and 13485 quality management systems

This 90-minute webinar will help you understand the competence and training requirements in the Quality Management Systems for medical devices, especially FDA QSR, ISO 13485, and even ISO 9001.

NSAI has named five members to its independent Certification Oversight Board to assure impartiality during certifications

Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of

Medical Contract Manufacturer Ranked No. 665 on the 2011 Inc. 5000

Medical CM Among the Fastest Growing, Privately-Held Companies in the Philadelphia Region

Round Rock, Texas – (August 29, 2011) – Cerilliant Corporation announces certification to ISO 13485:2003, Quality Management System for Medical Devices, adding to its existing accreditations of ISO Guide 34, ISO 17025 and ISO 9001.

This medical device quality systems training will show how you can design and maintain your quality system to meet requirements to target the US, Canada and EU.

This training will show how you can handle customer complaints in compliance with FDA and ISO Regulations. We will discuss the best ways to document customer feedback, what constitutes a complaint, what do with "non-complaint" feedback.

TNMC Medical Devices (Andre ten Napel) assisted Beier Drawtex Healthcare to obtain ISO 13485 and MDD 93/42/EEC Annex II Certification for its wound dressing

Continuous innovation and high demand within Medical and Healthcare electronics is leading to high growth opportunities for Embedded Equipment designers. Join us to get some real insight into the regulatory side of this business.

TechTrade has achieved ISO 13485 certification for its Ready-Heat Disposable Medical Heating Blanket with assistance from Emergo Group.

The National Standards Authority of Ireland is teaming up with the Kelmac Group to hold an IRCA certified QMS auditor/lead auditor training course based on ISO 9001:2008 and ISO 13485:2003 in Chicago during June 2011.

Pre-Submission Technical Evaluations can help speed up the time your medical devices get on the global markets.

Quality and Management Consulting Firm Offers Fast Track ISO certifications

Medical CM Among the Fastest Growing, Privately-Held Companies in the Philadelphia Region.

Palmdale, CA, October 15, 2010 — Senior Systems, an award-winning Electronics Manufacturing Services (EMS) provider, announced today that it has received ISO 13485:2003 Certification to manufacture medical devices at its Palmdale, CA facility.

Recognized for continued exceptional growth, Inteprod LLC, Eagleville, Pa, has been ranked as one of the 2010 fastest-growing, privately-held businesses in the Philadelphia region.

Offers solutions for Quality Management Systems of International Standards such as ISO Standards, NON ISO Standards, Auditing & Calibration, Trainings & Software Development, Six sigma, SA 8000, Ce mark, ISO 27001:2005, ISO/TS 16949:2002 etc.

The process is expected to be complete by the fourth quarter of 2010.

Vancouver, BC-Based Evasc Medical Systems has received ISO 13485 Certification for its vascular products

QARACC's 2-Day QMS Training course was designed for medical device manufacturers looking to gain a thorough understanding of the quality system compliance requirements for the distribution of medical devices domestically and internationally.

Medical Device management system certification

Mar-Med has received ISO 13485 certification on its Tourni-cot product from the National Standards Authority of Ireland

The National Standards Authority of Ireland, a leader in medical device certifications, has named Alfred Au its new U.S. Operations Manager

Agency to Pursue ISO 9001:2008 and ISO 13485 Certification

This issue of the monthly Whittington e-Newsletter provides articles on 1) Code of Ethics for Consultants, 2) Outsource Your Internal Audits?, 3) FMEA 4th Edition, 4) ISO 9001:2008 Status, and 5) ISO 38500 for IT Corporate Governance.

This issue of the free monthly Whittington e-Newsletter provides articles on 1) Ask EPA, 2) Outsourced Processes, 3) Calibration Software, 4) Energy Management, and 5) AS9100, AS9110, or AS9120.