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medical device record

A Breakdown of the FDA’s Medical Device Record Requirements

Listed within the FDA’s 21 CFR 820 are detailed regulations governing medical device records and quality systems. These regulations identify five record types that medical device manufacturers need to maintain. These include the Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), Quality System Record (QSR), and Complaint Files. Manufacturers must keep these records for the anticipated lifetime of the medical device or a minimum of two years from the date of first distribution. Additionally, they must store these records in a way that is easily accessible to anyone within the organization involved in quality-related activities. While ... Read More

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brainstorming techniques

4 Brainstorming Techniques That Generate Successful Ideas

Brainstorming can be a fun exercise to solve a particular problem or expand on an idea. As an inventor, you probably already have an idea of where you would like ... Read More
are you ready for production webinar

Webinar: Are You Ready For Manufacturing?

No matter what your product is, the end goal is to make it to production. Make sure your product is ready by watching this free webinar. Synectic President Adam Lehman ... Read More
cardiac catheter fixture

Case Study: Creating a Custom Fixture for Medical Device Assembly

The challenge Fixtures are used in product development and manufacturing for a variety of purposes. Most commonly they are used as a holding or support device, ensuring that all components ... Read More
custom pcb board

Case Study: How to Create Custom PCB Prototypes Using a Laser Cutter

The challenge Printed Circuit Boards (PCB), are used to mechanically support and electrically connect electronic components in an organized way.  They contain traces, or tracks, of copper sheets that are ... Read More
how to write a pds

How to Write a Product Design Specification (PDS)

The product specification also referred to as a product design specification, product development specification, or PDS, is a written document that describes your product and lists what you would like ... Read More
structural foam molding

The Basics of Structural Foam Molding

Structural foam molding, like gas assist, is another manufacturing process in the plastic injection molding family. The process creates a singular large and complex part that normally requires many components to complete. In ... Read More
gas assist injection molding

All About Gas Assist Injection Molding

Gas assist injection molding is a specialized technique in the plastic injection molding family. Like structural foam molding, gas assist creates an inexpensive lighter part compared to traditional injection molding. Given its versatility ... Read More
overmolding

An In-Depth Look at Overmolding

Manufacturers have been using plastic injection molding for over 150 years in every aspect of manufacturing. As the world of plastic molding grew, so did the need for additional molding practices ... Read More