Davide Mercadante

Davide Mercadante, Biogen - Qepler Summits And Conferences

Davide Mercadante

Sr. Associate, Product Development Quality (PDQ) – Device Development Quality (DDQ)
Biogen
Zug, Switzerland

Davide Mercadante is a medical engineer with 10+ years of experience within multiple areas of device and combination product development, including design & development, design quality assurance, verification & validation engineering, quality control and supply chain quality. He received his bachelor’s and master’s degree in medical engineering from the Second University of Rome, where is focus was on medical device design and development.

Davide has a Lean Six Sigma Green Belt and he currently works at Biogen in the Device Development Quality group where he is the quality project lead for both the Risk Management Continuous Improvements and Combination Product DHF 21CFR Part 4 Final Rule enhancement projects. He also has been instrumental with the integration of software as a medical device into the existing Quality Management System.

Related Sessions:

Qepler - Drug/Device Combination Products Summit thumbnail Details

Drug/Device Combination
Products Summit 2018

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2018
  • Berlin, DE
  • Pharma
Day 2: Wednesday, 05 December 2018
BLOCK: INTEGRATING DESIGN CONTROL AND HUMAN FACTORS.
CASE STUDY: Design Control, Human Factors and Risk Management. An integrated approach.
  • Combination product definitions and development process overview
  • Intended use as central key for the entire development
  • How Design Control, Risk Management and Human Factors interact each other in the process
  • Design Validation and PMS
View Details
Qepler - 2nd Annual Pre-Filled Syringes Summit thumbnail Details

2nd Annual Pre-Filled
Syringes Summit 2019

Enhance expertise sharing in developing pre-filled syringes and provide attendees with ample networking opportunities.
  • 04 Jun 2019
  • Barcelona, ES
  • Pharma
Day 1: Tuesday, 04 June 2019
BLOCK: REGULATORY AND QUALITY CONSIDERATIONS.
CASE STUDY: Risk Management for Injectable Combination Products.
  • Definitions and primary Regulations
  • Overview of Risk Management activities for Combination Products
  • Contact Points between Risk Management and Design Control
  • Intersection of Usability Engineering and Risk Management to create a good design for the Users
  • Beyond Development: Risk Management during lifecycle
View Details
Qepler - 2nd Annual Drug/Device Combination Products Summit thumbnail Details

2nd Annual Drug/Device
Combination Products Summit 2019

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2019
  • Prague, CZ
  • Pharma
Day 1: Wednesday, 04 December 2019
BLOCK: LCM CHALLANGES WITH DRUG/DEVICE PRODUCTS.
CASE STUDY: Understanding a device framework - risk management, design controls, and systems complexity.
  • Combination Product Definition and Regulations on Design Control and Risk Management
  • Risk Management as Central pillar to guide the Development of Combination Product
  • Integrated development Approach
  • Design Validation and Post Marketing
View Details
Qepler - 3rd Annual Pre-Filled Syringes Summit thumbnail Details

3rd Annual Pre-Filled
Syringes Summit 2020

Enhance expertise sharing in developing pre-filled syringes and provide attendees with ample networking opportunities.
  • 28 May 2020
  • Prague, CZ
  • Pharma
Day 1: Thursday, 28 May 2020
CASE STUDY: To Be Announced
View Details
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