Sean Blackall’s Post

I am super pumped to share that we have officially kicked off our podcast, aimed to support early stage MedTech companies! Check out episode #1 below, and make sure to subscribe as we have several more episodes coming in the near future. #medtech #startups #quickvault #veevamedtech

EXCITING NEWS!!! Today we launched our new podcast called QuickTalk by QuickVault. QuickTalk is your go-to podcast offering invaluable insights tailored for early-stage #MedTech companies. Our carefully curated content spans various topics and is strategically selected to drive commercial success for your startup. With episodes targeted to just 15 minutes, we provide concise yet comprehensive coverage of critical areas, ensuring easy consumption without compromising depth. Tune in to learn about specific topics and walk away with actionable strategies to propel your #startup forward. Whether seeking guidance on regulatory compliance, market entry strategies, or funding avenues, QuickTalk equips you with the knowledge and tools necessary to thrive in the competitive MedTech landscape. In this premiere episode of QuickTalk, we learn about the changes to the #FDA medical device regulations, which are being updated to align better with the #ISO 13485 standard. These changes commenced in early 2024, and medical device companies have 24 months to update their #QMS and internal processes to align with the new regulations.  With special guest Carolyn Algar Guthrie MS RAC from Helix Medical Watch Episode #1 here: https://lnkd.in/gcjrDhxV Tune in as we explain what this means for you and share some practical tips for achieving compliance. Be sure to subscribe so you don't miss future episodes of #QuickTalk and accelerate your journey toward success in medical technology innovation.

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. Top takeways from this episode: 💡 1. Alignment of R&D and Production: Ensure that testing environments and protocols in R&D align with the standards of production to avoid costly discrepancies and rework. 🛠️ 2. Regulatory Understanding Across Teams: Companies need to educate teams on the specific regulatory standards that apply to their product types to avoid misinterpretation and gaps in compliance. 🖥️ 3. Cross-Departmental Collaboration: Maintaining a startup-like collaborative culture, even as the company scales, is crucial for innovation and quality. 🎧 LISTEN NOW: https://lnkd.in/esW2zCZ8 #MedTechMan #FDA #Regulations #R&D

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. Top takeways from this episode: 💡 1. Alignment of R&D and Production: Ensure that testing environments and protocols in R&D align with the standards of production to avoid costly discrepancies and rework. 🛠️ 2. Regulatory Understanding Across Teams: Companies need to educate teams on the specific regulatory standards that apply to their product types to avoid misinterpretation and gaps in compliance. 🖥️ 3. Cross-Departmental Collaboration: Maintaining a startup-like collaborative culture, even as the company scales, is crucial for innovation and quality. 🎧 LISTEN NOW: https://lnkd.in/eH4U_2nS #MedTechMan #FDA #Regulations #R&D

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. Top takeways from this episode: 💡 1. Alignment of R&D and Production: Ensure that testing environments and protocols in R&D align with the standards of production to avoid costly discrepancies and rework. 🛠️ 2. Regulatory Understanding Across Teams: Companies need to educate teams on the specific regulatory standards that apply to their product types to avoid misinterpretation and gaps in compliance. 🖥️ 3. Cross-Departmental Collaboration: Maintaining a startup-like collaborative culture, even as the company scales, is crucial for innovation and quality. 🎧 LISTEN NOW: https://lnkd.in/esW2zCZ8 #MedTechMan #FDA #Regulations #R&D

If you want to know what the FDA has to say about eSTAR... Ask them. 👇👇👇 Recently, Michelle Lott, RAC, and MedTech Leading Voice did just that as a follow-up act to our recent eStar 5.0 expert webinar. 👉 Ping me for the webinar replay. Here's a taste of what we discussed with Patrick Axtell, Assistant Director for Tools and Templates with the FDA's CDRH. FDA eSTAR 5.0 Questions and Answers: Q1: Mandatory Adoption of eSTAR for Submissions Q2: Inclusion of Other Q Submissions in eSTAR Q3: Import-Export Functionality in eSTAR Q4: Handling Text and Attachments in eSTAR Q5: eSTAR as a Learning Tool (Sandbox) Q6: Acceptable File Types in eSTAR Q7: Documenting Previous FDA Interactions in Pre-Submission Q8: Issues with CDRH Portal for Large eSTAR Submissions Q9: Preference for Word or PDF Documents in eSTAR Q10: Submitting Risk Analysis and Mitigation in Traditional 510(k) Submissions Q11: Addressing Attachment Failures in eSTAR Q12: Difference Between "Refuse to Accept" and Technical Screening Q13: Switching Between Auto-Generated and Custom 510(k) Summaries Q14: Detail Level Required in eSTAR Text Boxes Q15: Acceptance of Manual Summaries in eSTAR Q16: Completeness of Text Elements in eSTAR Q17: Confidentiality of eSTAR Submission Content Q18: Biocompatibility Submissions in eSTAR Q19: Handling Standards and Documentation in eSTAR Transition Q20: Cybersecurity Considerations in eSTAR Version 5.0 Q21: Additional Cybersecurity Questions Coming Soon: A special issue of MedTech Leading Voice of the Q&A. In the meantime, check out the podcast below. #fda #estar #510k #medicaldevices #cybersecurity #cdrh

Issa K. recently joined The Global Marketing Show podcast by Rapport International to discuss key strategies for medtech companies navigating regulatory challenges. As Ambrosia Ventures’ principal consultant, I emphasized: • Early Engagement: Connect with regulatory bodies early. • Global Perspective: Understand international requirements. • Continuous Learning: Stay updated on regulatory changes. A big thank you to Wendy Pease 🌍 for having us as a guest! At Ambrosia Ventures, we specialize in helping medtech companies navigate complex regulations and accelerate innovation. Let’s connect to align your strategy with the latest trends! https://lnkd.in/g5bC7uP4 #MedTech #RegulatoryAffairs #Innovation #GlobalStrategy #AmbrosiaVentures

Hey #Pharmacists! Feeling the pressure of medication errors, staffing gaps, and regulatory juggling? You're not alone. But here's some good news! Introducing the #PrimeRx Pharmacy Podcast Trends, your partner in navigating today's #pharmacy challenges and thriving in the digital era. Learn more here: https://lnkd.in/ep9sTR9q

#podcast Sonia Veluchamy, CEO and Co-founder of Celegence discusses the increasing regulatory requirements and complexities faced by the medical device industry. Celegence works with companies to streamline their regulatory data management processes and adopt advanced technology solutions to manage compliance efficiently. Medical device companies are often slower than pharmaceutical companies to recognize the need to invest in data governance and process optimization to maintain compliance and avoid fines, delays in product approval, and loss of market access. #Celegence #RegulatoryAffairs #RegTech #RegulatoryStrategy #Pharmaceuticals celegence.com https://lnkd.in/gH2zmSC3

💡 Regulating Medical Devices and Cosmetics: CDSCO's Essential Role 💡 The Central Drugs Standard Control Organization (CDSCO) is not just about medicines—it also oversees the regulation of medical devices and cosmetics to ensure quality and safety for consumers. 🔬 Medical Devices CDSCO classifies medical devices into risk categories and mandates compliance with safety standards. From life-saving equipment to diagnostic tools, every device undergoes strict scrutiny before entering the market. 💄 Cosmetics For cosmetics, CDSCO ensures that products meet safety standards, are free from harmful chemicals, and are labeled correctly. This protects consumers from adverse effects and builds trust in the market. 📌 Why This Matters: With growing awareness, businesses in the medical device and cosmetic industries need to align with CDSCO regulations to thrive. Compliance isn't just a legal requirement—it's a commitment to safety and quality. 📌 How CorpBiz Can Help: Navigating CDSCO regulations can be complex, but that’s where CorpBiz comes in! ✅ Assistance with CDSCO registration for medical devices and cosmetics ✅ Guidance on compliance with safety and quality standards ✅ Expert support for documentation, audits, and regulatory submissions ✅ End-to-end consultation for businesses entering the Indian market At Corpbiz, we simplify the compliance process so you can focus on growing your business. #CDSCO #MedicalDevices #Cosmetics #Compliance #HealthcareInnovation #Corpbiz https://lnkd.in/gZJCPxFt