Vista Regulatory Solutions, LLC (VRS) helps start-up to mid-sized medical device companies to bring their innovative products to market. VRS offers efficient and cost-effective Regulatory Affairs and Quality Systems consulting for global companies. The Founder of VRS, Thomas Dold, has over 25 years of hands-on experience and brings new ideas, strategic plans, and a pragmatic approach to his client projects. Tom Dold, Founder & Principal Consultant at VRS, has authored several 510(k) submissions and successfully received FDA Clearance for medical devices in multiple segments of the medical device industry. He has also compiled several Technical Files successfully obtaining CE Marking for numerous devices. With global experience, VRS can assist you in accessing markets including North America, South America, Europe, and Oceania. For medical product manufacturers, quality systems and medical device regulations are a necessity. But for the team at Vista Regulatory Solutions (VRS), we see it as more. We work with innovative medical companies across the globe that create life-changing products. From simple medical instruments to more complex disease diagnosing products, our clients’ medical devices make a meaningful difference in people's quality of life. VSR is honored to be a part of getting our clients’ products to market, impacting lives, and making a difference across the globe. With each product launch, we are celebrating with you! Our Regulatory Affairs Services & Expertise: - Regulatory Planning and Strategy Development - Regulatory Compliance - Global Regulatory Submissions - Regulatory and Quality System Due Diligence - FDA QSR/cGMP, MDD, CE Mark - and more... Our Quality Systems Services & Expertise: - FDA QSR - 21 CFR Part 820 - Canadian Medical Device Regulations - ISO 13485: 2016 - EU Medical Devices Regulation (MDR 2017/745) - Medical Device Single Audit Program (MDSAP) - Internal and Supplier Audits, Gap Analysis and Assessments - and more...