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Medical Device Quality Systems Consulting

Choose quality over quantity with QA Consulting

Our personalized approach keeps the Quality Assurance process efficient, smooth and simple. Let our expert team analyze your company’s specific needs and develop pragmatic quality systems that meet your objectives, without the information overload.

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Why partner with quality system regulations experts?

We use proven quality assurance guidelines to help businesses avoid roadblocks and unnecessary risk. By outsourcing your most nuanced tasks to our Quality Assurance specialists, you’ll keep your medical device development on track and ready to deliver on time. We guarantee clients will learn from the process, and leave this partnership equipped with quality system regulations competency.

Take what you need, and we will do the rest.

Meet Anne: QA Consulting’s Founder and CEO, Anne Holland. From startups to Fortune 500 companies, medical device manufacturers of all types seek out Anne to develop and implement compliant solutions that meet their quality and regulatory needs. Regulatory device and compliance agencies often call her their expert witness. Her team is ready to be your business’s regulatory partner.

The close relationship I had with the QA team made for an easy process. As our company sought to commercialize a new medical device product, their knowledge and expertise helped us get the Perilav system to market.”

– James B. Stiehl, MD, Founder, Stiehl Tech, LLC

Embrace our global quality systems expertise

Customer satisfaction, for your medical device company, begins with a well-designed Quality Management System (QMS). The possibilities for an impactful medical device should be limitless. Our team of experts will use this system to get your device ready for the global market with these goals in mind.

Adherence to ISO 13485 is the first step towards compliance with European regulatory requirements. Compliance in this area shows regulators your quality system is effectively contrived and maintained.

We have a 100% success rate on passing FDA inspections and notified body audits. These results hold after helping over 50 medical device manufacturers design and implement Standard Operating Procedures (SOPs) for their quality management systems, in Europe, the States and worldwide.

When you work with QA, our team is your team. Our experts will bridge the knowledge gap and guide you through the continuum of medical device development and commercialization.

Our medical device quality consulting experts can help you find individualized solutions for:

Let us lay the foundations for your success.

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Safety first: being prepared for MDSAP

Unlike other medical device quality consulting providers, we assist with MDSAP readiness and compliance and conduct MDSAP readiness audits. The Medical Device Single Audit Program (MDSAP) allows for a standardized, global approach to auditing and monitoring medical device development.

This process raises the bar for the acceptable standard of device safety. Many medical device innovators don’t understand the true benefits of good QMS design. This blinds them from the positive impacts on patient outcomes and quality of life. Borrow our course-correcting quality strategy to get the most out of your development and dissemination budget.

With a client list spanning the globe, QA Consulting experts are skilled in navigating the necessary FDA and partner activities required to prepare for market. Our targeted approach starts with a gap analysis of your existing compliance. This allows us to identify tailor-made system improvements and preparation (including mock audits) that ensure your device survives the rigorous MDSAP process. Prepare for success in all major medical device markets, including:

  • Brazil
  • Canada
  • Europe
  • Japan
  • United States
Learn about MDSAP Audits

More than quality regulations paperwork

When implemented correctly, quality system regulations enhance your performance and, ultimately, lead to the success of your medical device. Lean into our deep expertise for medical device regulatory and quality strategy. Outsourcing to consultants saves resources by enlisting expert help to appraise your technical documentation and showing you where best to invest your efforts. Step-by-step guidance for good-quality QMS reduces cost, saves time and gets your device to the end user, in the unit of weeks not months.

Regulatory and quality procedures go hand in hand, but the power of a fully-integrated QMS is often underestimated. FDA routinely inspects Class I, II and III medical devices using a Quality System Inspection Technique (QSIT). Inspectors use this “top-down” approach to stress-test your product at any time, and so well-kept records of your QMS conformity is a must.

Maintaining an up-to-date QMS is vital for device approvals and registrations. Cutting corners is not only dangerous, it can lead to recalls, lawsuits, and injury to those who your product aims to help. Avoid common pitfalls by employing medical device quality consulting experts. Our team’s approach is personalized, goal-directed and efficient. We understand regulatory and quality assurances are more than just boxes to tick.

Get Help with Regulatory Requirements

The QA Consulting Advantage

Helping medical device manufacturers understand and navigate regulatory and quality processes is what we do best. It allows our clients to establish a stronger position for themselves and their innovations in the global markets — while providing a personalized solution that meets their unique goals and needs.

The end-users of your life-changing medical devices will benefit from your decision to partner with a quality affairs expert that understands the market, indications, and the internal processes required to bring your product to market safely.

Our team of regulatory insiders has an open door policy. That means they’ll keep you up to date on the latest industry practices and regulations. Our risk-mitigating regulatory strategy and educational approach to knowledge transfer provides a safe environment for clients to learn from the industry’s best and brightest without taking on any of the risk.

We value longevity and are here for you every step of the way.

Learn more about the QA Consulting team

Additional QA Consulting Services

In addition to our wide range of Quality Assurance expertise, we offer expert services for Regulatory Compliance and Microbial Testing Consulting:

medical device quality systems analysts on a laptop
quality systems cover

Take a look at the brochure to discover how our rich real-world knowledge can supplement your in-house team, and guide you towards impeccable quality compliance for your medical device.

Learn more about our QMS expertise, auditing experience, and why we are your trusted outsourcing partner.

Download the Brochure

Have a specific quality assurance need not listed above?

Contact our team to learn how we can help you establish and maintain your medical device quality assurance programs.

Set up a discovery call!