• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » Understanding the Medical Device Single Audit Program (MDSAP) audit process

Understanding the Medical Device Single Audit Program (MDSAP) audit process

July 25, 2018 By Danielle Kirsh

Eamonn Hoxey, BSI Group

The Medical Device Single Audit Program–MDSAP–was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of quality management systems (QMS). Health Canada’s decision to require an MDSAP audit to maintain Canadian Device Licenses is leading to a rapid increase in use of the program.

There is a set formula to calculate the time allotted for an audit, based on the number of processes that are carried out. The MDSAP Consortium have recently updated the procedures for calculating the duration of an MDSAP audit. As a result, there could be reductions in audit duration for smaller manufacturers.

The MDSAP audit is based on 13485:2016 with the applicable regulatory requirements of the participating jurisdictions–Australia, Canada, Japan, Brazil, USA–included as areas of focus. The MDSAP Companion Document identifies the audit tasks that have to be covered and the links to the applicable regulatory requirements for participating jurisdictions. The training material for MDSAP audits is available on the US FDA website under CDRH Learn (go to Quality Systems – Inspections – Global Harmonisation). MDSAP documents are also publicly available.

An MDSAP audit uses a process approach, based on a foundation of risk management, to select samples of procedures and records to examine. The audit process is described in the MDSAP Audit Model. The audit focus is on how risks are identified and addressed. This is investigated using four primary processes and three supporting processes, in the following sequence:

  • Management is the first primary process to be examined to assess the commitment of the organization’s Top Management to planning and implementing the quality management system. The supporting process of Market authorization and registration examines the maintenance of the necessary approvals, clearances and registrations. The relationship between the organization and the entity acting on its behalf in each jurisdiction is reviewed.
  • Measurement, analysis and improvement is next. The processes for preventing and correcting nonconformities are assessed. Processes associated with nonconformance events will be highlighted for further evaluation. The supporting process of Adverse events and advisory notices is considered.
  • The process for design and development is examined, focusing on recently introduced or changed devices and devices associated with nonconformance events. The application of risk management and the transfer of the output of design and development into production are areas of focus.
  • Production and service controls are then reviewed, looking at how controls on production are planned and implemented.
  • The Purchasing process supports all the primary processes and focuses on examples of the purchase of both goods and services identified as associated with highest risk activities, new product introductions or design changes. This also includes review of the adequacy of controls on processes outsourced to external parties.

Nonconformities are classified with a numerical classification from 1 to 5 using the grading system developed by the Global harmonization Task Force (GHTF).

Audits conducted to MDSAP follow this closely prescribed process of defined tasks that the auditors have to perform. Understanding this process and sequence that will be followed is important in being able to prepare for your audit effectively. There is additional material on the BSI website that can help you implement your transition to MDSAP.

Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

Filed Under: Blog Tagged With: BSI Group

In case you missed it

  • CeQur is launching a discreet, convenient ‘wearable insulin pen’
  • Teva appoints former Vertex exec as new head of R&D, CMO
  • Enovis partners with Kelvi on hot and cold therapies
  • West Pharmaceutical Services debuts new needle syringe system
  • Titan Medical names Cary G. Vance as new president, CEO
  • Acutus completes first closing in left-heart access portfolio sale to Medtronic
  • FDA clears Intuitive, Siemens Healthineers imaging integration for robotic bronchoscopy
  • FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall
  • How safe is health information after the overturning of Roe?
  • Smith+Nephew opens new plant in Malaysia
  • BD launches combination COVID-19, flu, RSV diagnostic test
  • Zimmer Biomet creates independent nonprofit organization to reduce health disparities
  • Dexcom focuses on early diabetes diagnosis as COVID links emerge
  • Nasdaq grants Titan Medical 180-day extension to regain compliance
  • Aerin Medical reports positive 4-year results for VivAer treatment
  • Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials
  • How medical device companies are responding to abortion bans

RSS From Medical Design & Outsourcing

  • Supply Chain EVP Greg Smith sees fewer suppliers in Medtronic’s future
    All eyes are on Medtronic’s global operations and supply chain leader as he works to modernize its operations and scrutinize suppliers. EVP of Global Operations and Supply Chain Greg Smith anticipates fewer suppliers in Medtronic’s future, he said in an interview this week. Smith spoke with DeviceTalks Editorial Director Tom Salemi in his first published… […]
  • CeQur is launching a discreet, convenient ‘wearable insulin pen’
    CeQur designed its Simplicity device to make insulin delivery as seamless as possible for people with diabetes. When it comes to managing diabetes, CeQur wants to make insulin therapy as convenient as possible. For those who prefer to manage their own insulin delivery, the Simplicity device might just do exactly that. Simplicity, a wearable, disposable… […]
  • Meddux opens new facility in Colorado
    Engineering, design, development and manufacturing company Meddux announced that it opened a new facility in Boulder, Colorado. The new, 22,000-square-foot facility doubles the overall square footage from its previous location in Colorado. According to a news release, it helps the company to quadruple its product development area and double its manufacturing footprint. Meddux’s new facility… […]
  • Reducing the Overall Cost of Validation
    By PTI Engineered Plastics Reliable medical devices and equipment are essential for researchers and doctors to accurately diagnose and treat a wide range of diseases. That is why there is such stringent oversight from the FDA to ensure these products meet the necessary requirements and specifications. To ensure compliance with regulators, manufacturers follow installation qualification… […]
  • BBS Automation has a deal to buy medtech supplier Kahle Automation
    BBS Automation said it plans to purchase high-speed automation supplier Kahle Automation to expand its medtech and life sciences business. Kahle will operate as Kahle – a BBS Company, according to a news release from Munich, Germany-based BBS and Lombardy, Italy-based Kahle. The deal is subject to regulatory approval. Terms were not disclosed. Kahle’s co-owners —… […]
  • How safe is health information after the overturning of Roe?
    The U.S. Department of Health and Human Services today issued guidance meant to better protect women’s health information as state abortion bans kick in after the U.S. Supreme Court’s overturning of Roe v. Wade. Despite the HHS actions, women may still wonder whether their health information is entirely safe going forward — a potential challenge… […]
  • Dexcom focuses on early diabetes diagnosis as COVID links emerge
    New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure. In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said. Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s… […]
  • Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials
    Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home. A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year. Salt… […]
  • How medical device companies are responding to abortion bans
    Days after the U.S. Supreme Court’s decision to overturn Roe v. Wade’s protection of abortion rights, medical device companies are among those reassuring workers about healthcare access. Corporate communications to employees and the public at large come as trigger laws in nearly half of the states outlaw abortion immediately. Some medtech companies are not using… […]
  • Philips updates on testing results for recalled ventilators
    Royal Philips (NYSE:PHG) says only a small portion of returned respiratory devices displayed the sound abatement foam degradation that sparked a massive recall. Repeated ozone cleaning may have made the problem worse. Those were some of the major takeaways from an update Philips provided today on a comprehensive test and research program it implemented after its… […]
  • ResMed names Lucile Blaise as new Sleep & Respiratory Care leader
    Lucile Blaise will be the new president of ResMed’s Sleep & Respiratory Care business starting July 1, ResMed (NYSE: RMD) said today. She replaces Jim Hollingshead, who became president and CEO of Insulet (Nasdaq:PODD) on June 1. ResMed President and COO Rob Douglas is serving as interim president of the Sleep & Respiratory Care during… […]

Primary Sidebar

DeviceTalks Weekly

July 1, 2022
Boston Scientific CEO Mike Mahoney on building a corporate culture that drives high growth results
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS