Regulatory Progress Associates (RPA)

Located in the Toronto, Ontario (Canada) region, Regulatory Progress Associates (RPA) are experts in the field of Medical Device Regulations and the processes that govern their sale in many regions including: USA, Canada, Europe, Latin America and Australia. In addition to medical devices we also cover other regulated products such as pharmaceuticals, cosmetics and natural health products. Our extensive experience with regulatory bodies such as US FDA and Health Canada ensures that you will follow the correct path to establishing and maintaining compliance with regulations. Product Specialties include: -Implantable (artificial knee, hip, screws, etc) -Picture Archiving and Communication Systems (PACS, RIS, HIS, etc) -Medical Devices that contain software or are software based -Electronic Devices (both sterile and non-sterile) -Catheters, IV Bags -Surgical Equipment (including Endoscopes, Scalpels, etc) -Cardiac (pacemakers, cardiac sutures, etc) -Many low risk devices as well such as Bandages, Wound Dressings ...many others, too numerous to list. Service Specialties include: -Quality Management Systems (QMS), ISO 13485, FDA's QSR, European MDD, etc -Sterilization Specialty (ISO 11135, ISO 11137) -Dealing with FDA/Health Canada audits (including response to warning letters, 483s) -Managing Clinical Trials in Canada and USA -We can set you up from initial product concept right down to manufacturing and post marketing activities

• Employees 10
• Founded 2009
• Annual Revenue $15172000