About Susan Bush

Susan has over 20 years working in the field of Regulatory Affairs and Quality Systems. In 1996 she started her career in Regulatory Affairs and Quality Systems upon joining J-Lloyd Medical, Inc., a right heart catheter manufacturer. It was here that Susan was introduced to the establishment and maintenance of an FDA and ISO 9001 compliant Quality System.

In 2001 Susan then continued her career at Origio, Inc. (formerly Mid-Atlantic Diagnostics), a company that provides sterile disposable products and equipment utilized in the field of In-vitro fertilization. It was here that she once again given the responsibility to develop and maintain a Quality System compliant to FDA QMS and ISO 9001/ISO 13485/CE marking.

Susan executed various tasks at both companies such as document control, writing/updating procedures, internal auditing, documenting and following up on customer complaints, corrective/preventive actions, development and maintenance of design history files and technical files, maintenance/validation of Class 8 cleanroom and various equipment maintenance/validation records.

However, while employed at Origio, Susan’s responsibilities grew to include successfully obtaining FDA 510(k)   Premarket Notification clearance for sterile and non-sterile Class II devices.

In 2014 Susan started her own company, Lloyd and Bush Consulting. She is currently assisting clients with preparation and submission of 510(k) Premarket Notifications, Establishment Registration and Device Listing. Susan also provides assistance to domestic clients whose imported product is held up by US Customs and Border Patrol.

Susan has a Bachelor of Science in Animal Science from Cook College Rutgers University.