2023, Canadian MedTech and the Holidays!

Hey,

Thanks for opening this first edition of the Regulatory Raconteur newsletter.

This monthly publication will focus on the impact of #Regulatory and #Quality Assurance on #MedTech businesses with a slight emphasis on the Canadian ecosystem. But first a quick look back on an "unusual" year.

Celebrating Canadian MedTech in two very short stories

->The importance of doing things Right the First Time

We believe so much in this approach that we made it our moto. Back to our MedTech start-up, a leading research group seeking clearance for a device that will change the lives of many women reached out to us for help with their regulatory strategy and filing. Despite inconsistent risk classifications for their device in different jurisdictions, this small team remained committed to generating the required clinical evidence for more stringent markets, establishing, and maintaining Design Controls, and following through with our regulatory recommendations. As a result, conversations with major regulators went very smoothly and they are well on track to obtain clearance.

->Managing the impact of talent scarcity

I think many Medical Device leaders will identify with this, a simple departure from the QA/RA team can lead to an accumulation of non-conformances and if your RA/QA team was a one (wo)man show, that could mean months without an QA/RA department. Initially, this company needed help with a US FDA requirement, but the newly hired QA/RA person uncovered additional issues and needed our support to address several non-conformances and CAPAs in preparation for an upcoming annual surveillance audit. The company passed their annual QMS surveillance audit with flying colors and closed all non-conformances preventing custom issues and protecting their business.

We are very proud of these two teams working hard to support their employer’s bottom line. Well done! You know who you are.

If any or both of these stories sound familiar or you know someone who could benefit from such support, I would love to have a conversation with you, feel free to send me a direct message on LinkedIn or book a 30 min call.

CE Marking to access the largest jurisdiction in the world

This year, the #EU #MDR was on everyone’s mind and next year will be the same.

If you intend to remain on the EU, UK, Switzerland, Australia/New Zealand, ASEAN and the Middle East markets make sure you don’t miss the QMS upgrade deadline of May 2024.

If you have any questions or are contemplating an EU-MDR QMS upgrade or CE marking under the EU-MDR feel free to book a 30min strategic meeting with me. I would love to learn more about your situation.

Looking forward: 2024

-> Open (hybrid) Monthly MedTech Roundtables

I keep having the same conversation with MedTech start-up leaders on building a peer-learning community, and decided 2024 will be it!

We will be running a monthly MedTech focused roundtable to brainstorm everything from design requirements to Quality Management System and Regulatory clearance. The idea is to have a 15-minute presentation on a specific topic, followed by a group discussion.

If interested, please reply with the words “interested in roundtable” in the subject line. Seats will be limited to 7 people per session and there is one time application process to qualify attendees. If you have any suggestions on topics, questions, or ideas please add those to your email response.

Thanks for reading and please share with others and don't forget to subscribe.

Wishing you all the very best to you and your loved ones.

Peace,

Hasnaa