Best Selling Medical Devices Courses - Web Seminars Package

Pack of 40

Best Selling Medical Devices Web Seminars Package in 2015-16 from World Renowned Experts

Pack of Ten

A CAPA Primer - Elements of a CAPA Program

FDA Regulation of Combination Products

Complaint Handling for Medical Device Manufacturers

Complaint Handling in Compliance with FDA and ISO Regulations

"Zero Defects" and the cGMPs - Pros and Cons

Complaint Handling and Management: From Receipt to Trending

What does FDA require for Medical Devices Manufacturers to Do When Filing an Adverse Event Report (MDR)

Medical Device Product Development Process

Software FMEA for Medical Devices

CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

A second look at 510(k) changes

Design Controls - Requirements for Medical Device Developers

Lyophilization Technology

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

"Regulatory Aspects of Advanced Therapy Medicinal Products in the EU"

FDA Regulation of Medical Device Software

Product Information in the EU

FDA Regulation of In Vitro Diagnostics

Medical Devices - ISO 13485 – Do You Really Know What You Need To?

Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements

Device Changes, FDA Changes, and the 510(k)

FDA Export Certificates for Medical Devices

Similarities and Differences Between an FDA and MHRA Audit

Medical Device Registration & Listing, and Inspection Follow-up Activities

Medical Device Recalls

Bullet Proof 510(k) – Latest FDA Changes to the Process

Corrective Actions - Current Expectation of ISO 13485 and FDA Auditors

Draft Guidance for Device Industry and FDA - Postmarket Surveillance

Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products

Postmarketing Vigilance Reporting For Medical Device Manufacturers

Sterile Medical Packaging Design - 7 Essentials

Accelerated Aging Techniques for Medical Device Packaging

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

FDA - Legal Writing Skills that Result in Effective Regulatory Submissions

The Master Validation Plan - The Unwritten Requirements

DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions

Drafting a Software V&V Documentation Package and Protocol

Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration

Designing Medical Devices for Long Life at Lower Costs

Construct and Manage the Technical File and Design Dossier

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