How to avoid a medtech document scavenger hunt
Take a few moments to consider the importance of the documentation of your medical device company.
Take a few moments to consider the importance of the documentation of your medical device company.
The IEC 60601 standard is one part of putting together a technical file or a 510(k) submission. It’s about more than electrical safety — it covers mechanical safety, labeling, and risk management.
March 31, 2019, is the date by which all companies that are currently 13485 certified need to have transitioned to the 2016 regulations. Here's a checklist of what medical device companies need to do to comply.
The main reason for the latest publications on SaMDs by both the FDA and International Medical Device Regulators Forum is to bridge regulatory gaps that have resulted from the proliferation of app development and smartphone usage.
From the EU MDR/IVDR being revised to the MDSAP program going live, regulatory changes have been rampant and significant for medical device professionals.
I would anticipate that for some companies, the patient reported outcome information and data raises the bar. PRO data will be used to help demonstrate that a product is high quality, safe and effective.
Share some of the trends you are seeing among your clients across healthcare, including chronic conditions, behavioral health, healthcare navigation, and more.
The FDA has arrived at your premises. What is your reaction? Are you ready? Here are some of the issues that we commonly see medical device companies trip over.
Here's a compilation of myths and realities about Corrective Action and Preventive Action (CAPA), the system for addressing systemic quality issues for medical device companies.
Failure to adequately put complaint procedures in place has been a relatively common reason for the FDA to issue a warning letter.
Corrective Action and Preventive Action (CAPA), a system for addressing systemic quality issues for medical device companies, is frequently overused, which can overburden businesses with unnecessary work, or when underutilized, trigger FDA warning letters.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
One major mistake companies frequently make is the practice of treating design controls as a chore to get out of the way. A robust design control practice aligns with regulations and allows you to be flexible and innovative.
There tends to be a lot of confusion over FDA regulations for medical device companies and often, important compliance issues are missed. Here's a look at four of the most commonly occurring notification reasons from 2016.
From a new FDA commissioner to 510(k) review times, here's what to expect in the way of medical device industry changes this year.
The medical device Design History File is the proof companies will need to give the FDA that all of the design control regulations were assiduously followed.
Nearly 70 percent of 510(k) submissions were rejected the first time round between January and June of 2015. Here's what you can do to reduce the likelihood of that happening to your company.