For most medical devices, the road to market includes a gate for 510(k) clearance before the device can be marketed. Completing the product development process and creating the deliverables necessary for submission can take months if not year. However, once development is completed delays in getting to market can impact the bottom line. In 2015, only 22% of devices where cleared within the initial 90 day review window. Only about 60% where cleared within 6 months. This webinar will explain the 510(k) submission process and provide tips on planning for a successful submission.
Areas Covered in the Webinar:
This webinar will provide valuable assistance to medical device companies in managing their Design History Files. The employees who will benefit include:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over twenty-five years of experience in the Medical Device industry. Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems. She has been responsible for establishing processes and leading groups of engineering in the following disciplines: Risk Management, Requirements Management, Verification and Validation, Process Improvements, Project Management, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.