Mercedes Massana
Principal Consultant at MDM Engineering Consultants
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 thirty 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: Systems Engineering, 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.
Upcoming Webinar
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Recorded Webinar
Creating a Good Design History File (DHF) for Audit Success
This webinar will cover the basics on how to maintain a good Design History File (DHF) that will help a manufacturer in a regulatory compliance audit. The webinar will cover the structure of a DHF and steps to ensure that the DHF is completed as the design and development process progresses. The DHF needs to be maintained as design changes are performed. Information in the DHF can help facilitate design decisions, which often can affect the safety of the device. The DHF provides the knowledge base needed for the manufacturer to maintain the device. It also provides the secrets to a successful Design Control audit.
Recorded Session Get life time access for one participant with download option!

Learning Design Controls through Review of FDA 483 Observations
This webinar will provide participants with key knowledge of medical device design controls by analyzing FDA 483 observations and learning what the agency is looking for with respect to each design control element.
Recorded Session Get life time access for one participant with download option!

Creating a Good Design History File (DHF) for Audit Success
This webinar will cover the basics on how to maintain a good Design History File (DHF) that will help a manufacturer in a regulatory compliance audit. The webinar will cover the structure of a DHF and steps to ensure that the DHF is completed as the design and development process progresses. The DHF needs to be maintained as design changes are performed. Information in the DHF can help facilitate design decisions, which often can affect the safety of the device. The DHF provides the knowledge base needed for the manufacturer to maintain the device. It also provides the secrets to a successful Design Control audit.
Recorded Session Get life time access for one participant with download option!

Using an IQ / OQ / PQ Approach to Validating Medical Device Software
This medical device software validation training will show how you can validate software using IQ / OQ / PQ methodologies, typically employed for medical device process validation.
Recorded Session Get life time access for one participant with download option!

Key Considerations in Verification & Validation of Medical Devices
This medical device verification and validation training will dissect some of the FDA 483 observations related to design verification and design validation, and provide key information on how they can be prevented.
Recorded Session Get life time access for one participant with download option!

An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971
This webinar will cover all major elements of ISO 14971 and present a methodology for integrating the requirements of this standard into the product development process to ensure that the requirements of the standard are met, and the medical device is designed to be safe and effective. The webinar will specify how risk management activities are incorporated in all phases of development and other related processes (CAPA, Complaint Management, Non-Conformances), and what supporting documentation needs to be gathered in order to ensure that decisions made based on what is learned as part of the risk management process are adequately justified and documented.
Recorded Session Get life time access for one participant with download option!

Creating a Good Design History File (DHF) for Audit Success
This webinar will cover the basics on how to maintain a good Design History File (DHF) that will help a manufacturer in a regulatory compliance audit. The webinar will cover the structure of a DHF and steps to ensure that the DHF is completed as the design and development process progresses. The DHF needs to be maintained as design changes are performed. Information in the DHF can help facilitate design decisions, which often can affect the safety of the device. The DHF provides the knowledge base needed for the manufacturer to maintain the device. It also provides the secrets to a successful Design Control audit.
Recorded Session Get life time access for one participant with download option!

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