Design Controls

Software as a Medical Device

Software as a Medical Device

Software-related medical devices are taking over the medical device industry. There are three types of software-related medical devices in the industry software as medical devices, the software is integral to medical devices, and software used in the manufacturer or maintenance of a medical device1. Software that is….

Investigational Device Exemption

Investigational Device Exemption

An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data….

Concepts of Modern Quality systems

Concepts of Modern Quality systems

A quality system’s main purpose is to consistently produce safe and effective goods while also guaranteeing that these actions are sustainable long term. It should be emphasized that putting in place an effective quality system in a manufacturing company will take a substantial amount of time and effort. By incorporating effective knowledge-building methods into day-to-day operations, a strong quality system will improve…

How to Submit a 510K

How to Submit a 510K

Three types of Premarket Notifications can be submitted to the Food and Drug Administration (FDA) Traditional, abbreviated, and special 510Ks. The traditional 510K program is utilized to seek marketing authorization for any device. When submitting a 510K there is not a form to submit however submission requirements can be found under 21 CFR part 807.

Top-Down Quality

Top-Down Quality

Quality within an organization is everyone’s responsibility. From the highest-level executive to the intern who just...

DFMEA

DFMEA

The Failure Mode and Effects Analysis (FMEA) tool allows an organization to examine the possible hazards and risks...

Design Outputs

Design Outputs

Part of the design process is the development of what is known as Design Outputs. According to the FDA “Design Outputs...

Design Transfer

Design Transfer

‌  The design and development process is long and challenging. At the end of the process comes what is known as...

Making a Design History File

Making a Design History File

‌  A Design History File, DHF, is part of the requirements set by the FDA and other regulatory bodies for the...

Developing Design Controls

Developing Design Controls

Design controls are a necessary and critical element in the QMS and overall development of any medical device or...

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