Medical Devices
- The medical devices industry is a knowledge based business, and that means one of its most important resources is skilled, knowledgeable people.
- Developing medical devices requires skilled personnel who understand all the current compliance requirements for developing your products.
- Medical Devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III.
- Most Class I devices are exempt from Premarket Notification 510(k)
- Most Class II devices require Premarket Notification 510(k)
- Most Class III devices require Premarket Approval.
- The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:
- Establishment registration
- Medical Device Listing
- Premarket Notification 510k, unless exempt or Premarket Approval (PMA)
- Investigational Device Exemption (IDE) for clinical studies
- Quality system (QS) regulation
- Labeling requirements and Medical Device Reporting (MDR)
- Our team at PharmaBio Staffing is dedicated to providing you the skilled people you require to support all of your recruitment needs within each of your departments.
- We will provide you a staffing plan for each of your products and work with you to ensure that you are adequately resourced throughout your product development process.
- Our experienced team strives to understand your current corporate timelines and challenges within your organization, and then subsequently matches your requirements with the skilled personnel necessary to achieve your product development goals.
- Whether you are searching for advice on developing a Premarket Notification 510k, or Premarket Approval (PMA) or setting up manufacturing suites or performing clinical trials, we can help you achieve your goals within your timeline.
- We have access to experienced Permanent, Contract and Consulting personnel at all levels within Clinical, Chemistry, Manufacturing, Quality, Nonclinical, Regulatory and Commercial.
- Contact us and find out how PharmaBio Staffing can Deliver Results with Quality people.
