Straightforward, honest, medical device knowledge. We focus on making the nuance of medical devices, simple.
Medical Device How
HI THERE. WE’RE MEDICAL DEVICE HOW.
How to make “it depends” an actionable answer.
At Medical Device How, we’re hyper-focused on helping our clients with direct answers.
Personalized Medical Device strategies for your present and future.
Needs change from day-to-day. One day you need to write a Human Factors protocol. The next day you need to route 20 documents for approval. We can support you on a wide range of activities with one contract, one training record, and one point-of-contact. As a small start-up, you want it simple, and Medical Device How makes that possible.
Cybersecurity
To be successful in your Digitalization journey, you need to keep your data, and your customers’, safe. This is challenging in the current environment as the threats keep shifting, as do the expectations from the regulators. At Medical Device How, we utilize our Medical Device knowledge, as well as our experience in military cyberthreat analysis, to provide customized Cybersecurity for you and your patients.
Medical Device QMS Training
Focused training on Design Control concepts and connections with other QMS processes, such as Risk Management and Process Controls. Training focuses on learning key concepts to enable your associates to truly understand the nuances of Design Control, in an interactive and engaging setting.
Are you graduating and looking to get into Medical Device Regulatory/Quality or Research & Development as a career? We offer job guidance and coaching to help set you up for the career that is right for you. We also provide mock interview sessions with RA/QA and R&D hiring managers to help you get the job you want.
Start-Up Support
There are Design Controls, and then there are Design Controls. The documentation of the design is innate to a device and innate to the regulations. Design Controls are a natural output of a well-designed product and should not be thought of as additional work that needs to be done to keep some future auditors happy.
Design Controls
Digitalization
There is Digitalization, and then there is Digitalization. Anyone can take a document and scan it into a computer and claim it is now digital. That does not help your business, nor your compliance status, and just costs you money. Real digitalization starts with understanding what data is important and how to break your work product into that data. Smart digitalization acts as an enabler to get you not just where you want to go, but where you need to go.
ARTICLES FOR MEDICAL DEVICE HOW
Medical Device Observations
OUR MISSION
Medical Devices acquisitions are difficult and can lead to compliance issues. This article contains a list useful Rules of Acquisition a company can take to ensure the acquisition is successful.