About Biggins Quality Solutions Consulting

Our Experience

At Biggins Quality, our consultants have 20+ years' experience in the life science industry. This gives us the insight to understand the challenges of medical device design and development.  Our expertise encompasses many unique products.  We are here to help you succeed in the realization of your product, from creating an effective quality management system to, understanding and navigating the intricacies of regulatory policies, and finding tailored solutions for you and your business. 

Why Choose Biggins Quality?

Our experience across the entire product life cycle of a medical device has given us the knowledge to identify what you need to be successful. We have the expertise to guide you through any compliance or quality issue that could affect your development process or business, and ultimately reach your goals. We offer continuous support to your team; from concept through device approval to end of use. Our services are focused in four areas: US and internationals regulatory affairs, quality assurance and compliance, product life cycle consulting, and clinical research services. Our domestic and international presence has provided our clientele with expert advice on the many facets of a product's life cycle including design, manufacturing, and post-market support.