4/23/2021
BY: BOB JENKINS
In response to the drastic industry and economic changes faced during the COVID-19 pandemic, many manufacturers have had to pivot to provide completely different parts or services in order to keep their businesses operating. As some continue to look for opportunities in other markets or sectors, a viable option can be found in the medical device industry.
In addition to providing critical supplies like personal protective equipment (PPE), the medical device industry is wide open for companies that offer services such as injection molding, welding, device sterilization and printed circuit board assembly. For those considering moving into medical device production, or those who already do some work in the space, a competitive advantage can be found with MedAccred.
ACHIEVE EXCELLENCE WITH MEDACCRED ACCREDITATION
MedAccred is an industry-sponsored accreditation program that aims to reduce risk to patient safety and assure quality products and compliance with requirements related to critical processes used in the production of medical devices. While some may already believe they know all there is to know about a certain critical process, they might be surprised to find several important areas for improvement through the MedAccred accreditation process. To compare, while ISO audits are a mile wide and an inch deep, MedAccred approaches manufacturing processes as an inch wide and a mile deep.
The creation of MedAccred was motivated by the industry wanting to do better. Using an existing certified quality management system (such as ISO 9001, ISO 13485 or AS9100) as a starting point, MedAccred questions were created by industry sponsors and hinge on the details that prevent manufacturers from becoming exceptional within their critical processes. Those who pursue MedAccred accreditation tend to discover things about their manufacturing processes they never knew before. This additional look at the process could not only prevent costly defects or waste in production, but also could save lives.
For example, life-threatening recalls of medical devices increased 9,811% between 2017 and 2018, with some recalls related to critical devices like pacemakers. Needless to say, that is not an easy product to recover or replace. Manufacturers of medical devices carry extra pressure and risk to produce parts that are perfect every time – and MedAccred ensures that happens.
To take your business to the next level – whether you are just joining the medical device industry or already a part of it – MedAccred will help you get there. For additional guidance with your MedAccred accreditation, The Center can help. As part of the Medical Manufacturers MedAccred Accreditation Pathway (MedMMAP) program, The Center’s quality experts can help close the gaps that keep your company from becoming exceptional to ultimately earn your accreditation and gain additional business in the process. Learn more here or contact us at inquiry@the-center.org.
Additionally, you can hear directly from MedMMAP Program Director Scott Schein at next week’s SAE annual conference. Scott will conduct his virtual presentation on April 29 at 12pm. Register for this free event here.
MEET OUR EXPERT
Bob Jenkins, Quality Program Manager
Bob Jenkins is a Quality Program Manager at The Center. In his role, he manages and delivers training and implementation assistance to organizations in the field of quality improvements. As an Exemplar Global Certified Auditor, Bob assists clients with Quality Management System implementations such as ISO 9001:2015 and IATF 16949. He provides internal auditor training and consulting services for various groups, including production, production management and corporate management, in disciplines involving the automotive core tools of quality systems consisting of FMEA, PPAP, APQP, SPC, MSA, and Root Cause Analysis/Problem Solving. Bob also teaches blueprint reading.
Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at www.the-center.org.
Categories: growth,
Medical Devices,
Quality Management