MedAccred

MedAccred

An industry managed supply chain oversight program that reduces risk to patient safety, assures quality products and compliance with requirements as they apply to critical processes used in the production of medical devices. For more information please contact us or sign up to receive regular Program news and updates.

NEWS

  • Medmarc Recognizes Importance of Supplier Controls to Mitigate Products Liability Risks

    Medmarc Recognizes Importance of Supplier Controls to Mitigate Products Liability Risks

    14 September 2016
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  • The Vital Link Between Critical Process Quality and Patients

    The Vital Link Between Critical Process Quality and Patients

    18 August 2016
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  • New Brazing Audit Criteria Released by MedAccred

    New Brazing Audit Criteria Released by MedAccred

    17 August 2016
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  • Bringing Nadcap to the Medical Industry: Feature Article in Power Transmission Engineering

    Bringing Nadcap to the Medical Industry: Feature Article in Power Transmission Engineering

    11 July 2016
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  • MDT Magazine Editor Identifies MedAccred as #1 Trend for Device Designers

    MDT Magazine Editor Identifies MedAccred as #1 Trend for Device Designers

    07 July 2016
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  • MPO Magazine Highlights MedAccred’s Role in Medical Molding

    MPO Magazine Highlights MedAccred’s Role in Medical Molding

    30 June 2016
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  • MedAccred Releases First Plastics Audit Criteria

    MedAccred Releases First Plastics Audit Criteria

    28 June 2016
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  • MedAccred Makes an Impact at Implants 2016

    MedAccred Makes an Impact at Implants 2016

    21 June 2016
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  • First Accreditation for MedAccred in Europe Awarded to Bodycote

    First Accreditation for MedAccred in Europe Awarded to Bodycote

    01 June 2016
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  • MedAccred at IMPLANTS 2016

    MedAccred at IMPLANTS 2016

    26 April 2016
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KEY INFORMATION

WHAT IS MedAccred?

MedAccred is an industry managed, consensus-driven approach to ensuring critical manufacturing process quality throughout the medical device supply chain.

WHY MedAccred?

In today’s world of global manufacturing, the supply chain is multi-tiered and geographically remote, making oversight challenging and costly. To prevent output deficiencies, critical processes and products must be validated during manufacturing to prove that they are fit for purpose, satisfy regulatory requirements and reduce overall risk. Download the Executive Brief

ACCREDITED SUPPLIER PERSPECTIVES

Global Technologies – Cable & Wire Harnesses

To promote their status as the first MedAccred Cable & Wire Harnesses accredited supplier in the world, Global Technologies produced a video which highlights their achievement.

To view the video, please follow this link.

BENEFITS

  • Provides consistent/standardized critical process accreditation accepted by the Medical Device Industry resulting in fewer redundant onsite audits by multiple OEMs
  • Conducts in-depth critical process audits that are compliant and consistent to accepted industry/technical standards and conducted by Subject Matter Experts
  • Provides greater visibility of the supply chain to all levels and sub-tiers that provide critical processes, consistent with regulatory requirements (e.g. FDA, ISO 13485, MDD, etc.)
  • Improves flow down of OEM requirements to sub-tier suppliers
  • Medical device industry-accepted and consistent technical requirements leading to process discipline, greater operational efficiency and continuous improvement resulting in higher quality and lower overall cost.

How does it work?

Audits are conducted on behalf of its subscribing OEM members using collaboratively created audit criteria. The accreditation is granted and accepted by the program’s subscribing OEM members. The audit criteria incorporates industry accepted performance standards and manufacturer specifications that meet the requirements of the regulator.

Process-focused Product Audits are conducted by industry approved and trained SME auditors, who have extensive experience and knowledge of their process.

MedAccred RESOURCE LIBRARY

What you need to know about MedAccred

Value Proposition

Executive Brief

MedAccred Auditor Overview

Introductory Training Session

Sign up for regular updates

To keep up to date with MedAccred activities, and receive news and information direct to your inbox, please sign up to our mailing list.

Contact us

Connie Conboy
Director, Strategy and Business Development
+1 724-772-7153
cconboy@p-r-i.org

Hannah Godfrey
Senior Specialist
+ 44 (0) 870 350 501
hgodfrey@p-r-i.org

Justin McCabe
Specialist, Research & Development
+1 724-772-8693
jmccabe@p-r-i.org

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MedAccred MEETINGS

Industry stakeholders participating in MedAccred meet regularly face-to-face and by telecon. Details of the meetings, including agendas and minutes, are provided below.

2016
2015
2014
2013
2012

COMPANIES ACTIVELY PARTICIPATING

An increasing number of medical device companies are actively participating in the MedAccred program. The below are just a few of the companies actively involved. Contact us for more information.

Abbott
Applied Thermal Technologies
Baxter Healthcare
BD
BMP Medical
Bodycote
Boston Scientific Corporation
Celestica HealthTech
DJO Global
DSM Biomedical
Flex
GE Healthcare
Global Technologies
GW Plastics
Hansen Balk
Harterei Gerster
Industrial Metal Finishing
Johnson & Johnson
Kimball Electronics
Lake City Heat Treating
Mack Molding
Medtronic
Microtech Welding
MTD Micro Molding
Nypro Healthcare
Paragon Medical
Paulo Products
Philips
Plastikos
RTE
Sanmina
SINBON Electronics
Solar Atmospheres
STERIS
Stryker
Synergy Health
Techmetals
Tecomet
Vention Medical