Thank you for visiting our website. Most of the people who visit our website are medical device or biotechnology companies with specific needs or concerns, either with FDA or their registrar.

We solve problems. We have more than 60 years' experience assisting healthcare, medical device and biotechnology companies worldwide.

If you are managing an FDA inspection or have a troublesome 483, we can help. We are experienced at working with FDA, and crafting responses that satisfy them and get you back to work quickly.

If you are ISO 9001/EN 46001/MDD compliant, and are wondering what else you need to do to comply with the Quality System Regulation, call us. We can help you achieve full QSR compliance quickly and cost-efficiently. We can also provide training to facilitate your understanding of the similarities and differences between the two systems.

If you wish to become certified to ISO 9001/EN 46001/MDD, we can work with you to achieve that goal very cost- and time-efficiently, and at the same time build a quality system that will serve as an important investment in your company's infrastructure.

Please take a few seconds to contact us online, and outline your needs or concerns. We will respond within 48 hours. Go to our Principals page to find specific information about James Stout, our senior quality consultant at Buckman Company, Inc.