EMMA International has entered into a strategic partnership with Thema, an Italian based strategic-regulatory consulting company. The goal of this strategic partnership is to expand geographical offerings to companies operating in the life sciences regulated space.
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
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
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
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.
Diversity Challenges in the MedTech Industry
The lack of representation in the medical device industry is not a new topic of discussion. The lack of representation...
ISO 13485 & QSR Harmonization
For several years there has been quite the buzz in the Med Device Industry about the potential harmonization between...
Material Science in MedTech
The field of biomedical engineering is a new, widely researched, and well-funded industry that aims to tackle problems...
Notifying CDRH of Device Shortages
COVID-19 has severely disrupted the medical device supply chain. Device manufacturers are typically not required to...