Our Experience
At Biggins Quality, our consultants have 20+ years experience in the life science industry, which gives us the insight to understand the challenges of medical device design and development. Our expertise encompasses many unique products, including those identified as combination products. Now, we wish to share that knowledge by guiding your team, large or small, to realize a successful product launch.
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 regulatory goals. We will continue to support your team during the product life cycle; from concept through device approval to end of use. Fundamentally, we want to give you the time and guidance you deserve.
Our services are focused in three areas: US and internationals regulatory affairs, quality assurance and compliance, and design and manufacturing consulting. Our domestic and international presence has provided our clientele with an expert witness on several facets of a product's life cycle including design, manufacturing, and post-market support. This service has been provided to both manufacturers and attorneys representing plaintiffs.
Supported Products
The type of products we can support include the following:
Our services are designed to empower your team and provide them with either guidance or the resources they need to succeed. Talk to us today about how we can support your development process, improve your compliance, and put you on a solid track to success with operational excellence in the manufacture of your product.
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