• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    New Breast Implant Surgery Guidelines to Enhance Patient Safety

    Rhythm Management Group Debuts RhythmSynergy Tech Platform

    FDA Approves Trial Completion for Virtual Incision's MIRA Platform

    Thermo Fisher Scientific, Matrix Clinical Trials Enhance Research Solutions

    Medtronic, DaVita to Create New Kidney Care Firm
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Injecting Neurostimulators into Blood Vessels (We Swear, It’s Not Sci-Fi)

    Understanding the Costs of Care in the OR

    Sick of Being Sick: Pandemic Fatigue Flares at AAOS

    Managing Critical Healthcare Supply Chains in Turbulent Times

    To Drive Value, Human Capital Leaders Turn to Outsourced Solutions
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.

    Trademark Plastics Inc.

    BMP Medical

    Cirtec Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing in Dental Prosthodontics, Orthodontics, and Surgery

    What New Tech Can Improve Your Medical Manufacturing Plant?

    Why Medical Device Firms Must Navigate the Muddy Waters of ESG Requirements

    Medical Device Servicing vs. Remanufacturing

    Digital Marketplaces for Medical Equipment Come of Age
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.

    Trademark Plastics Inc.

    BMP Medical

    Cirtec Medical
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Columns

    Maintaining Compliance in the Digital Age

    ...

    Maintaining Compliance in the Digital Age
    Related CONTENT
    • BMP Medical - Delivering Custom Plastics Manufactured Solutions
    • Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    • MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021
    • CE Mark Granted to Predictive Software for Kidney Allograft Survival
    • Medical Devices Market to Top $671.49 Billion by 2027
    James A. Dunning, Principal, QPC Services LLC09.07.18
    I’ve spent much of my professional life assessing regulatory compliance in the life sciences industry. In the past, there was always a clear difference between compliance and continuous improvement, but times have changed. The old (i.e., out of date) concept of compliance is no longer effective, especially with regard to the quality management system and its ability to support innovative new medical device design and manufacturing technologies. 

    In the July/August issue of MPO, I advocated the notion of selling regulatory compliance, so I obviously am not declaring compliance totally dead (yet). However, I do believe the concept of compliance is changing, especially within regulatory agencies, and the change is forcing medtech companies to take a new approach to compliance. The U.S. Food and Drug Administration and its supervisory sisters worldwide have adopted a new paradigm for the 21st century, and this new standard represents a significant change from traditional concepts. Some changes currently shaping the global regulatory environment include:

    • The Medical Device Single Audit Program—just one element of the global harmonization effort
    • A transition to the new Medical Device Regulations for Medical Devices and IVD devices
    • ISO 13485:2016—the latest version of this key medical device quality management system standard
    • The revision of ISO 14971—a key risk management standard for medical devices. The first draft document for the revision should be out later this year.
    • New guidance documents for complex medical devices and manufacturing processes, such as:
      • Software as a Medical Device
      • Technical Considerations for Additive Manufactured Devices
      • Manufacturers Sharing Patient-Specific Information with Patients Upon Request
      • Deciding When to Submit a 510(k) for Software Changes to an Existing Device

    Regulatory changes have become an inevitable part of medtech product development in recent years due to growth in complex devices and advanced manufacturing processes, as well as the ability to more efficiently generate, collect, and analyze data.

    Lean manufacturing and Six Sigma methodologies have affected compliance, too. During my tenure as a medtech employee and consultant, Lean and compliance responsibilities were often at odds within design and manufacturing operations. But now Lean and Six Sigma concepts are more accepted within the regulatory function. 

    Medtech’s shrinking product lifecycle has impacted compliance as well. Many new medical devices have shorter lifespans than their predecessors due to fast-changing technology, oftentimes incorporating advanced design, development, and manufacturing processes that require new assessment methodologies from regulatory bodies.

    The new regulatory compliance paradigm is tailor-made for today’s digital world. Post-market communication such as advertising and complaint reporting is almost instant and accessible through multiple avenues (internet, email, social media, etc.). The new regulatory paradigm takes the Electronic Age into consideration.
     
    Electronic quality management systems are becoming more common, even in startups and very small medtech companies. Often, multiple information technology systems interact with the quality management system. This increased connectivity and efficiency drives an increase in compliance expectations.

    Risk management for product safety has become a key component of the industry’s quality management systems. Risk-based decisions are now considered in assessing regulatory compliance.

    The merger of medical devices with pharmaceuticals and biologics (combination products) is one of the key reasons for the paradigm shift. The silos between these life sciences sectors are beginning to fall, and the quality system standards are aligning. Expectations for quality management system performance in these different sectors are also becoming more similar.

    Advancements in state-of-the-art medtech products, design, and development require teams that include people from multiple disciplines; likewise, today’s more complex manufacturing processes must involve people with specific expertise. Companies’ regulatory and quality teams must include members who can provide valuable input into the development and oversight of these complex processes. Improvements in device design and manufacturing often raise regulatory compliance issues, which requires collaboration among everyone involved in product development (even top management) to ensure regulatory compliance.

    Today, when I think of compliance, my thoughts are much different then they were just a few years ago. My paradigm has shifted, too. I now think for the better. 


    James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS). He can be reached at jdunning@qpcservices.com.
    Related Searches
    • design
    • u.s. food and drug administration
    • compliance
    • iso 13485:2016
    Suggested For You
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021 MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021
    CE Mark Granted to Predictive Software for Kidney Allograft Survival CE Mark Granted to Predictive Software for Kidney Allograft Survival
    Medical Devices Market to Top $671.49 Billion by 2027 Medical Devices Market to Top $671.49 Billion by 2027
    RapidPulse Closes $15 Million Series A Financing RapidPulse Closes $15 Million Series A Financing
    Midwest Products & Engineering Acquires MindFlow Design Midwest Products & Engineering Acquires MindFlow Design
    CE Mark Granted to Expandable, Biodegradable Biliary Stent CE Mark Granted to Expandable, Biodegradable Biliary Stent
    Joint Testing Shows Medical-Grade TPEs Bond Effectively to Copolyesters Joint Testing Shows Medical-Grade TPEs Bond Effectively to Copolyesters
    Bright Future Ahead for Renal Denervation Bright Future Ahead for Renal Denervation
    COVID-19 Accelerated Demand for Handheld Ultrasound Devices in China COVID-19 Accelerated Demand for Handheld Ultrasound Devices in China
    Closed Loop Thermal Control in Medical Devices Closed Loop Thermal Control in Medical Devices
    Westfall Technik Opens New Medical Molding Plant and Clean Room Westfall Technik Opens New Medical Molding Plant and Clean Room
    AdaptHealth Appoints Stephen Griggs as CEO AdaptHealth Appoints Stephen Griggs as CEO
    Putnam Plastics Corporation Completes Facility in CT Putnam Plastics Corporation Completes Facility in CT

    Related Content

    • BMP Medical - Delivering Custom Plastics Manufactured Solutions

      BMP Medical - Delivering Custom Plastics Manufactured Solutions

      Medical Contract Manufacturing, Design, Assembly & Packaging

    • Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Neela Paykel is serving as general counsel and Tom Teisseyre assumes the chief product officer position.
      Business Wire 09.22.21

    • MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021

      MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021

      Attendees of The MedTech Conference, powered by AdvaMed, will vote for the Grand Prize winner.
      MedTech Innovator 09.21.21


    • CE Mark Granted to Predictive Software for Kidney Allograft Survival

      CE Mark Granted to Predictive Software for Kidney Allograft Survival

      Algorithm gives the probability the graft will still be functional at three, five, and seven years after evaluation by a healthcare professional.
      Cibiltech 09.21.21

    • Medical Devices Market to Top $671.49 Billion by 2027

      Medical Devices Market to Top $671.49 Billion by 2027

      Wearables and rising cases of chronic diseases will help fuel growth, industry data predicts.
      Precedence Research 09.16.21


      Trending
      • 5 Ways Plastics Revolutionized The Healthcare Industry | Medical Product Outsourcing
      • Anumana's ECG Pulmonary Hypertension AI Algorithm Gains Breakthrough Status | Medical Product Outsourcing
      • FDA Clears Masimo's Neonatal RD SET Pulse Oximetry Sensors With Improved Accuracy Specifications | Medical Product Outsourcing
      • Medtronic, DaVita To Create New Kidney Care Firm | Medical Product Outsourcing
      • 7 Steps To Create Your Own Medical Device Marketing Plan | Medical Product Outsourcing
      Breaking News
      • New Breast Implant Surgery Guidelines to Enhance Patient Safety
      • Rhythm Management Group Debuts RhythmSynergy Tech Platform
      • FDA Approves Trial Completion for Virtual Incision's MIRA Platform
      • Thermo Fisher Scientific, Matrix Clinical Trials Enhance Research Solutions
      • Medtronic, DaVita to Create New Kidney Care Firm
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Cybersecurity Challenges Leave Medical Device Makers Insecure
      • Contract Design for Medtech
      • Diabetes Medical Device Technology Update
      • Medtech Full-Service Outsourcing Q&A 2022

      Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
      You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

      • About Us
      • Privacy Policy
      • Terms And Conditions
      • Contact Us

      follow us

      Subscribe
      Nutraceuticals World

      Latest Breaking News From Nutraceuticals World

      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports
      GC Rieber Foundations Expand Philanthropic Efforts
      Coatings World

      Latest Breaking News From Coatings World

      Sustainability, Economy are Focus of BCF’s Annual Conference
      Demand for Rhino Shield Increases
      ICP Receives ASC Innovation Award for Spray Foam That Meets Changing Environmental Regulations
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      New Breast Implant Surgery Guidelines to Enhance Patient Safety
      Rhythm Management Group Debuts RhythmSynergy Tech Platform
      FDA Approves Trial Completion for Virtual Incision's MIRA Platform
      Contract Pharma

      Latest Breaking News From Contract Pharma

      iECURE Enters Agreement with Center for Breakthrough Medicines
      CPDC Enters Clinical Manufacturing Deal with CellBion
      Olon to Build New R&D Center in Italy
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      K-Beauty Brand Siita Shares Plastic Decomposition Technology with the Beauty Industry
      Shellworks Raises $6.2 Million in Seed Funding
      Ulta Beauty Reports Record First Quarter 2022 Results
      Happi

      Latest Breaking News From Happi

      Honeywell Addresses Critical Issues Such as Sustainability, Workforce Training and Digitalization
      Monat Global Wins Four Stevie Awards in the 20th Annual American Business Awards
      Coty Expands Vegan Beauty Portfolio With New Rimmel Mascara
      Ink World

      Latest Breaking News From Ink World

      Orion to Finish Gas Black Expansion in Germany by Early 2023
      Richard Childress Racing Shows Off New Wraps for 2022 NASCAR Season
      ProAmpac Acquires Specialty Packaging, Inc.
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      UPM Raflatac accelerates label growth with acquisition
      Labelexpo Asia 2022 postponed
      Teklynx software helps Top Clean Injection validate labels
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Rael Raises $35M in Series B Funding
      Schobertechnologies Offers Rotary Web-fed Converting Solutions
      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Toetal Solutions Raises $1.02 Million in New Financing
      ManaMed's ManaSport Wearable Ultrasound Earns FDA Nod
      Ekso Bionics Names Jerome Wong as Interim CFO
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      onsemi Recognized by Fortune 500 for Its Transformation Journey
      LG Display Presents AI-Driven NFT Artwork on Transparent OLED
      Joe Stockunas Joins SEMI as Americas President

      Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

      AD BLOCKER DETECTED

      Our website is made possible by displaying online advertisements to our visitors.
      Please consider supporting us by disabling your ad blocker.


      FREE SUBSCRIPTION Already a subscriber? Login