Michael Winter, Rac Email & Phone Number

In my current position I manage my department’s budget and a group that consists of Engineers, Technicians, Managers, and Inspectors. Our department is situated at the corporate level and we support two separate companies within the Curbell corporate structure, Curbell Medical Products, Inc. and Curbell Plastics, Inc. Curbell Plastics has ISO 9001 certification and distributes and fabricates many types of plastic products. Curbell Medical Products is a manufacturer of medical devices and has ISO 13485 and MDSAP certifications. My primary responsibility includes all matters concerning quality assurance and regulatory affairs. Some of my activities within Curbell Medical include establishment registration and device licensing, device submissions, compliance and enforcement matters, consultation with legal counsel and various insurance agencies, communication with applicable regulatory bodies and our ISO registrar, and representation on all design projects. Over the course of my career, I have remained current with applicable medical device laws and regulations due to the requirements of our devices with respect to their distribution in the United States, Canada, the European Union, Australia, and New Zealand. Additionally, I have contacts with many ISO registration firms, representatives within the FDA and Health Canada, CE marking firms, and those that provide Authorized Representation and/or Notified Body services. Finally, I am the Official Correspondent to the FDA for Curbell Medical Products, Inc., and for all device license applications in those countries where we are registered/listed.Specialties: Regulatory Affairs, Medical DevicesQuality Assurance

Listed skills include Fda, Medical Devices, Quality Assurance, Spc, and 27 others.