Medical Devices - ISO 13485 – Do you really know what you need to?

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Deadline: May 23, 2016 | Date: May 23, 2016

Venue/Country: Online, U.S.A

Updated: 2016-05-06 15:04:31 (GMT+9)

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A detailed look at each section of the standard.

Real world examples of what to expect, and what to prepare and repeal within the audit guidelines.

What must a documentation system look and feel like to ensure compliance?

These and many other key details to ensure that your organization has the ability and knowledge to ensure that ISO 13485 is within your grasp.

Clean rooms 101, we can assist in what to do and what not to do. From the infrastructure, to the maintenance, PPE, etc. It is a holistic system that must be maintained at optimal standards at all times.

How is the quality within the organization? Materials must be accounted for and properly maintained. Only the highest quality materials should be utilized to create a unique and durable product.

Your suppliers must be chosen carefully. Ensure that each vendor is vetted and reviewed at least annually. The product you are making cannot be at or maintain any level of quality unless the supply chain is acceptable and consistent.

A true and complete internal audit is key to ongoing certification. The system must be looked at entirely each year, and by independent parties to validate that each section of the standard is being met, and is consistently documented to be functional. Who should audit which section, what type of documentation must be kept; this will be reviewed and explained.

Management plays a key role with any certification. Their support is needed to implement and maintain the system for certification. Their roles should be clear, and they must be involved in the annual review to ensure that the system overview is known and communicated to all. This way ongoing changes, both good and bad, are feed back into the system to keep it live and continually improving as a whole.

Areas Covered in the Session:

An overview of the standard and the different areas needed to create, maintain, and sustain a proper documentation system to ensure certification.

Know what to look for and where to prepare to enable one’s organization and personnel to assist in an audit for certification.

Clean rooms

Supplier demands

Quality from when materials are received, until after the devices leaves the facility.

Annual upkeep

Management representation and participation.

Who will benefit:

Quality Managers, EH&S Reps, Quality Control, QCQA, CEOs, Sales, buyers, vendors, etc.

Webinar includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Certificate of attendance