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5 BOLD Predictions for Medical Device Quality in 2022

In our upcoming webinar for emerging medical device companies, we will elaborate on these five bold prophecies, enabling you to peer into our crystal ball and prepare for new challenges as well as new opportunities- and a most productive and prosperous 2022!

1. FDA will formally announce the merge of QSR and ISO 13485
The plan will provide sufficient time for companies to transition. You can consider reviewing the official technical report, AAMI TIR 102:2019, published in 2019, that enables you to compare the requirements of QSR and ISO 13495. Please also note that the updated regulations will be very close to the current MDSAP regulations.

2. Digital Therapeutics will emerge as one of the leading medical device categories for investment and development
Both large and small companies will move to launch formal SaMD digital therapeutic devices in 2022. In addition to several guidance documents issued by the FDA distinguishing general wellness devices versus medical devices through the amended Section 520 of the FD&C Act, FDA issued an enforcement policy in April 2020 for digital health devices treating psychiatric disorders during COVID-19 public emergency. Release of the policy is intended to help expand the availability of digital health therapeutic devices for psychiatric disorders to facilitate consumer and patient use while reducing user and healthcare provider contact and potential exposure to COVID-19. Please refer to the blog post from RookQS describing this policy here.

3. MDR delays will require action from the EU
The current delays in receiving notified body designation under the current regulations will mount more pressure on all the stakeholders, and thus will lead to either significant changes to the current timeline of notified body designation, or to modifications in certain provisions from the regulations. Please stay tuned to RookQS as a series of blog posts and webinars specifically addressing MDR transition are underway.

4. Remote work will continue to be the norm for medical device companies
Tools like and other eQMS will allow the QMS to maintain compliance with less need for onsite work. eQMS will also substantiate the existing software development practices (e.g., Agile methodology) and tools (e.g., JIRA) to generate quality and regulatory contents toward market commercialization. Please refer to the blog post from RookQS offering working from home tips as a Medical Device QA here.

5. Rapid test breakthrough
Finally the time for rapid at-home testing in the U.S. will be widespread, with multiple regulatory and manufacturing hurdles removed, allowing for access to accurate OTC testing. For example, FDA is further streamlining the regulatory pathway for manufacturers developing over-the-counter at-home tests. FDA is providing recommendations for labeling updates to facilitate over-the-counter single-use testing for symptomatic COVID-19 individuals for tests currently authorized only for serial testing. These actions will help put more tests on shelves for people seeking an at-home test, unlocking more options and potentially lowering prices.

Stay tuned for a cordial invitation to our webinar in early January. If you have questions that won’t wait, we’re here whenever you need us.

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