SERVICES
Medical Device Regulatory Consulting Services
Together, We Can Accelerate Your Ideas to Market
The compliance process for your medical device can be complex, time-consuming and costly. But it doesn’t have to be.
With over 25 years of experience, QA Consulting will help you promptly develop and commercialize your medical device.
Let’s work together to overcome your regulatory challenges today.
Why Partner With Medical Device Regulatory Experts?
You know your medical device, and we know regulatory nuances.
Allowing specialists to plan and execute the most critical and time-consuming regulatory tasks helps avoid development delays and costly mistakes. Collaborate with our team of experts to implement time-saving, risk-mitigating regulatory strategies and compliance documentation.
Meet Anne: QA Consulting’s CEO and Founder 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
Lean Into Our Rich Expertise
QA Consulting team members are eager to share their wide range of Regulatory, Quality Assurance and Microbial Analysis knowledge with you and help commercialize your medical device as quickly as possible.
Together we can transform complex and time-consuming regulatory processes into easy-to-navigate, efficiently-achieved milestones.
We offer custom-tailored quality and regulatory solutions for medical devices in the EU and US. Some of our specialties include:
- CE Technical Documentation and Design Dossiers
- Clinical Evaluation Report (CER)
- Health Canada Licenses
- Good Laboratory Practices (GLP) support documentation
- Other country submissions, as requested
- De Novo Request
Avoid development delays and costly mistakes by outsourcing your most critical and time-consuming tasks to one of our specialists. With our FDA-experienced regulatory consultants at your side, we’ll help you accelerate the path from early filings through post-market compliance.
Borrow Our FDA Strategy (US)
Our medical device regulatory consulting experts want to help you develop a safe and successful medical device. As a knowledgeable FDA consulting partner, we can help you complete critical steps throughout the FDA landscape, including:
- Presubmission
- Request for Information
- Premarket Notification
- Premarket Approval (PMA)
- Investigational Device Exemption (IDE)
FDA regulations are complex and change often. Consider our medical device regulatory consultants as your eyes and ears on regulatory updates. They work as an extension of your in-house team to ensure you have a focused regulatory strategy that allows you to concentrate on your business rather than worrying about compliance.
Use Our MDR Strategy (EU)
Together, we can ensure your medical device obtains CE Marking and maintains access to the European market.
Leverage our expertise in MDR pre- and post-market regulatory processes:
- EU MDR Gap Analysis and Implementation
- CE Technical Documentation and Design Dossiers
- Clinical Evaluation Report (CER)
- Person Responsible for Regulatory Compliance (PRRC)
- Post-Market Clinical Follow-up (PMCF)
- Periodic Safety Update Report (PSUR)
Regulatory Strategy: More Than A Box To Check
Navigating regulatory requirements is essential to getting your medical device to market and in the hands of the end-user. We understand the tedium and frustration that comes with proper compliance. However, we believe that carefully planning your pre-market regulatory strategy is a worthwhile investment.
Putting resources into experts you can trust saves you time now and in the future. It ensures you are on the right path and that you avoid repetition, development delays, and costly mistakes.
At QA Consulting, we do not believe in a one-size-fits-all philosophy. Your needs are unique, and you deserve a personalized approach that’s custom-tailored to your company. That’s why we often kick off with a gap analysis of your QMS, followed by an audit of your technical documentation. The goal is to guide you through every regulatory requirement necessary for your success.
Let’s do it properly. Let’s do it early.
The QA Consulting Advantage
Helping medical device manufacturers understand and navigate regulatory 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 regulatory expert that understands the market, indication, and 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. Additionally, 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.
Additional Services
Take a look at our brochure and find out how you can meet your business objectives and expedite time to market. Learn more about our staff expertise, company credentials, and why we are your reliable medical device regulatory partner.
Have a specific regulatory need not listed above?
Our knowledgeable team is available to discuss and advise.
Looking to expand your organization’s regulatory capabilities? Consider outsourcing some or all of your regulatory affairs and compliance functions.
