How to avoid a medtech document scavenger hunt
Take a few moments to consider the importance of the documentation of your medical device company.
For electronic medical device developers, here’s what you need to know about IEC 60601 standard
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.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
A timeline to adopt medical device QMS (and why you need to act now)
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.
Here’s what you need to know about FDA’s new guidance on software as a medical device
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.
5 predictions for the medical device industry in 2018 (and how you can prepare)
From the EU MDR/IVDR being revised to the MDSAP program going live, regulatory changes have been rampant and significant for medical device professionals.
The potential impact of FDA’s use of PRO to assess effects of medical devices
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.
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A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
How to prepare your medical device company for an FDA inspection
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.
Debunking 8 commonly held CAPA myths
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.
What are the best ways to handle medical device customer complaints?
Failure to adequately put complaint procedures in place has been a relatively common reason for the FDA to issue a warning letter.
What should trigger a CAPA in medical device manufacturing?
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.
Maximize Revenue and Patient Care with Strategic Weight Loss Management
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Correcting misconceptions about FDA design controls for the medical device industry
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.
4 key compliance issues for medical device companies
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.
5 predictions for the medical device industry
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.
3 tips for managing your medical device design history file
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.
6 tips to reduce likelihood of a rejection for an FDA 510(k) submission
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.