The Best Medtech Quality Assurance Out There

Quality assurance for your medtech business is a critical factor to the success of your device, yet is all too often overlooked for some reason or another. But as regulations, compliance and acquisition increase for medical device companies, so does quality assurance spending. When it comes to the success of your medical device company, you don’t want to leave quality—and ultimately your reputation—to chance.

QuickConsult offers quality assurance services for all aspects of the medtech industry. Our innovative medtech consulting services let you pick the expert right for your needs. Whether you need fresh expertise or second opinions for your medtech startup or Fortune 500 company, QuickConsult can connect you with the information you need fast.

Our experts can help you build a quality assurance system from scratch or we can assess your Quality Managemetn System (QMS) as it stands. Looking for room for improvement or if your QMS is up-to-date is critical to the long-term success of your medtech company and products.

Why You Need Medical Device Quality Assurance

Being out of touch with quality assurance systems and standards in the medical device industry can quickly turn to disaster. Some common quality assurance pitfalls include:

  • Conducting quality management reviews infrequently
  • Not covering all the applicable local or international standards
  • Failing to follow through on management review outputs
  • Lacking documented rationale behind your management representative selection
  • Inadequately documenting attendance and topics that were covered as part of the  review
  • Inadequately documenting nonconforming product investigations
  • Waiting too long for supplier responses to nonconforming product inquiries
  • Not keeping a good internal audit trail
  • Allowing the appearance of bias
  • Failing to use a risk matrix for internal audit scheduling
  • Improperly auditing your audit program
  • Having poorly defined CAPA timeframes
  • Allowing a disconnect between root cause and corrective action

From suppliers to design to manufacturing, you need quality assurance for your medical device company. Don’t get caught with bad products or poor design, only being forced to recall your product later on. Stay up to date with national or international quality standards for your device. In a study conducted by Best Practices, LLC., a benchmarking research and management consulting firm, found that regulations and compliance were the main reason for increased emphasis and spending on quality assurance from 2012–2015 across 21 surveyed medtech companies. In order to reduce warnings letters and to keep up with global standards, these companies have placed larger portions of their budget with quality assurance measures.

Quality assurance measures should be happening from inception to creation of your medical device. QA steps can include training, document control in the case of audits, design, quality engineering and inspections. Of the surveyed companies, inspection and production of medical technology devices required the most amount of quality assurance spending to ensure that the ultimate goal of helping patients with quality products could be met.

QuickConsult’s Quality Areas of Expertise

QuickConsult is your premier connection to the industry’s most experienced medtech experts and consultants. From ex-FDA regulators to vice presidents of Fortune 500 companies, you can rest assured that whoever you choose to work with has been there and done that—including med tech quality assurance. Some common areas of QA expertise include:

Six Sigma

Six Sigma is a methodology used to essentially eliminate all defects in product and process. “To achieve Six Sigma, a process must not produce more than 3.4 defects per million opportunities,” which can be an extremely difficult goal. Our experts at QuickConsult can help you begin your journey toward and achieve Six Sigma with the guided help and advice of our Six Sigma experts. Start eliminating defects in your med dev manufacturing, products and services today.

ISO 13485

ISO 13485 is to act as an updated quality management standard. These are the requirements that medical device manufacturers must incorporate into their quality management systems. But beyond manufacturing standards, ISO 13485 also requires med tech companies to adhere to customer requirements, risk management and effective processes. By meeting ISO 13485 requirements, your company will be meeting FDA Quality System Regulation (QSR) requirements as well as other global regulatory requirements. Understanding the process and requirements of ISO 13485 can be tricky, though. Instead of hiring an ISO 13485 expert, add QuickConsult experts to your team as cost-effective supplemental staff with all the ISO 13485 know-how you need.

QSR 21 CFR 820

QSR 21 CFR 820 ensures medical devices consistently meet applicable requirements and standards and that companies follow quality systems. This helps ensure design control and product quality. If you’re unsure how to navigate QSR 21 CFR 820, talk with QuickConsult today.

While these are common murky areas when it comes to quality assurance in the med tech industry, you can also come to our network of experts for:

  • Risk Management
  • Design Controls
  • Complaint Handling
  • Document Control Systems
  • Gap Assessments
  • Audits
  • Postmarket Compliance
  • Production and Process Controls
  • Product Development Quality
  • Supplier Quality
  • Process and Manufacturing Quality
  • Equipment Qualification
  • Process Validation
  • Nonconformances / Corrective and Preventive Action (CAPA)
  • Define, Measure, Analyze, Improve, and Control (DMAIC)
  • Design History File (DHF)
  • Device Master Record (DMR)
  • Statistics
  • Verification and Validation

The Importance of Med Tech Quality Assurance

No matter the size of your med tech company, don’t get caught with out-of-date quality standards or with none at all. Over the years, there have been major product recalls that deliver huge blows to the trust, reputation, profit and innovation capabilities of a company. For example, in 2010, Boston Scientific had to recall implantable defibrillators, making shares fall 13% overnight and causing the company to lose $5MM every day the faulty devices were off the market. Similarly, Medtronic’s shares dropped 12% in 2007 after the company had to stop selling a product: It ultimately paid a $268MM legal settlement in 2010.

Massive corporations might be able to scrape by and survive a recall as a result of poor or no quality assurance, but many companies would be forced to fold after such a hit. By ensuring you meet up-to-date quality assurance standards and you have supreme quality systems in place, you can sleep at night knowing your products and processes meet and exceed the maze of quality requirements in the med dev industry today.

QuickConsult Is Your Hub for Quality Experts

We have the depth and breadth of expertise you need across numerous product and therapeutic areas, including but not limited to cardiac rhythm, cardiovascular, diabetes, general surgery, neurological, reconstructive/plastic surgery, vascular therapies, mobile apps and more. No matter your quality assurance needs, our experts can help you from start to finish whether your business is brand new or a seasoned industry vet.

“I wish there had been a QuickConsult in my quality system toolbox in past situations. I think of the time and energy that would have been saved. This new service should prove to be a valuable asset for those responsible for a company’s quality system.”

– Gary Chambers, Quality System Management Professional

Helpful Links

FDA – Understanding Barriers to Medical Device Quality

FDA – Quality System (QS) Regulation/Medical Device Good Manufacturing Practices

ISO 13485:2003

ISO 14971:2007

 

 



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