It’s time to recap what happened in the medical device industry this year and start to think about what’s expected to happen in 2019. Some of the highlights of the show include: ● 2018 Prediction #1: It’s going to be harder for medical devices to get to market and stay in the market in EU. Still confusing; clarity to come in 2019? ● 2018 Prediction #2: Mad dash to update ISO 13485 certification before deadline. Resources were constrained, some came late to the party, progress was made. ● 2018 Prediction #3: ISO 14971 will be revised for industry comment. Draft was released in September/October to receive comments. Be on the lookout for a revision around mid-year. ● 2018 Prediction #4: Health Canada will back off on MDSAP deadline. Would have provided constraints for many companies, but Canada didn’t back down. ● 2018 Prediction #5: Medical device companies shift from compliance-focused to quality-focused. FDA’s been proactive, some movement, but a long way to go. ● 2019 Prediction #6: Wearable medical devices will become more common. A trend with more consumer good companies entering medical device market. ● 2019 Prediction #7: EU MDR challenges. Will still be more difficult and unclear on how to get products to market. ● 2019 Prediction #8: FDA QSR harmonizing with ISO 13485:2016. FDA is interested in moving away from 21 CFR Part 820 for ISO 13485. Prepare for it! ● 2019 Prediction #9: The FDA’s Case for Quality. It’ll continue and gain momentum. Initiatives include Medical Device Discovery Appraisal Program. ● 2019 Prediction #10: Expect FDA to continue to shake up regulatory submission processes. Modernizing 510(k) process into Safety and Performance-based Pathway.