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A Closer Look at ISO 13485 for Medical Device & Equipment Manufacturing

CMTC Manufacturing Tech

Reduces the Risk of Product Defects As a QMS Standard, ISO 13485 was designed to help medical device manufacturers and equipment suppliers develop strong quality management systems from the ground up. regulations which are more detailed procedural requirements.

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3D Printing for Aerospace – Quality Requirements

Additive Manufacturing

All of these devices are foundationally built within the organizations’ quality management system (QMS) that is compliant to and certified to meet the AS9100D Standard. All 3D printing systems used in the aerospace field need to be based on a strong quality management system.

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How to Implement a QMS in Your Organization

CMTC Manufacturing Tech

To address these needs, manufacturers need to implement quality management systems (QMS). This blog will cover the top questions surrounding quality management systems in manufacturing: What is a QMS in manufacturing? What are QMS documents? What is a Quality Management System (QMS)?

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Intro to ISO 13485 for Medical Device Manufacturers

CMTC Manufacturing Tech

To truly succeed at regulatory compliance and become a player in national and international markets, organizations must invest in implementing leading quality, safety, and regulatory standards such as ISO 13485. What is a Quality Management System (QMS)? Clause 4: Quality Management System.

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Why Aerospace & Defense Needs a Vertical MES 

iBASEt

Every action throughout production and testing must be by the book and accurately documented with required reviews and sign-offs. Standards such as AS9100 Rev D require quality management systems covering everything from product safety and risk management to counterfeit parts prevention.

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Implementing Quality Systems for Medical Devices: Aligning with Business Goals

Additive Manufacturing

When new to medical device development and manufacturing one daunting aspect can be developing a Quality Management System (QMS). Many industries use QMS or similar principals, so why does it seem so much harder to apply them to medical device quality systems driven by regulations? Change Control).

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How to Foster Innovation Through a Culture of Education, Mentoring

Mold Making Technology

A Dynamic sampling event is meticulously structured and documented and will employ complete thermal control at the projected cycle to help define the process corners. One of the most effective ways to learn how to build a mold is to take an existing one and disassemble it while evaluating and documenting each component.