BraunSolutions Regulatory Group

Consulting services for Small Business Medical Device companies; specializing in US FDA compliance 21CFR 820, cGMP, CAPA, 510(k)'s, PMA's, IDE's, 513(g) submissions, ISO9001:2015, ISO13485:2016 Technical writing: Custom quality manuals, standard operating, and business procedures experience. Senior Auditor: FDA and ISO QMS regulations. Acting QA & Regulatory Affairs Director for several medical device manufacturing companies. Medical Device Design, Device Approval, and all documentation related to these activities. FDA Consultant offering smaller medical startups assistance in understanding and maintaining FDA standards in manufacturing and marketing. Client countries; United States, Canada, UK, South Korea, China, Czech Republic, France, Italy, and Poland.

• Employees 2
• Founded 2003