QMSphere reposted this
Season’s Greetings from QMSphere! Wishing you a joyful season, meaningful quality time to recharge🔋, and a strong start into 2026.🚀 Thank you for the inspiring conversations and collaborations this year.🌐
QMSphere
Business Consulting and Services
San Diego, California 50 followers
Helping life science companies stay compliant, audit-ready, and globally competitive
About us
Welcome to QMSphere QMSphere is your dedicated partner in Quality Management & Regulatory Compliance, helping MedTech and Pharma companies in Southern California and nationwide navigate complex requirements with confidence. We specialize in: Sterilization Validation European Regulations Auditing At QMSphere, we don’t just consult—we collaborate. We believe in building lasting relationships, delivering tailored solutions, and empowering your teams to maintain quality and compliance long after our work is done.
- Website
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www.qmsphere.com
External link for QMSphere
- Industry
- Business Consulting and Services
- Company size
- 1 employee
- Headquarters
- San Diego, California
- Type
- Self-Owned
- Founded
- 2025
- Specialties
- ISO 13485, ISO 9001, Auditing, Quality Management, Medical Devices, QM Processes, Improvement, Sterilization, European regulations, Risk Management, Validation, and Supplier Management
Locations
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Primary
Get directions
4037 Governor Dr
San Diego, California 92122, US
Employees at QMSphere
Updates
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🚨 MDR / IVDR: Major Commission Proposal Published Today 🚨 The European Commission has published its proposal to amend MDR (EU 2017/745) and IVDR (EU 2017/746) Key proposed changes 👇 🔥 No more mandatory 5-year recertification cycles → Certificates subject to risk-based periodic review instead 🧠 Clinical evidence becomes more proportionate → Broader clinical data, more flexibility on equivalence → Expanded use of non-clinical & in-silico evidence 📉 Notified body burden reduced → Fewer tech doc reviews, remote audits, less frequent surveillance → Unannounced audits only for cause ⚙️ Administrative reduction → PRRC rules simplified → Longer vigilance timelines 🌐 Digital by default → Digital DoC, tech documentation & submissions ⚠️ It's still a proposal, so not set in stone What are your thoughts on the proposal? (see link to the document in the comment below, Chapter 5 gives an overview of the changes)
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QMSphere reposted this
Last week brought two exciting milestones: I attended a fantastic Biotech Networks event and completed my first client audit here in California. Driving home afterward, I was reminded how energizing it is to build new connections and support companies in strengthening and improving their quality systems — and yes, the view on the way back was simply unbeatable. Feeling very grateful. ✨ If you’re still completing your 2025 audit plans, I’m happy to support! #AuditReadiness #QualityManagement #LifeSciences #QMSphere #MedTech #Biotech #Auditing #ISO13485
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Happy Thanksgiving from QMSphere - wishing everyone a day filled with gratitude and joy. #Gratitude #Thankful #Appreciation #Leadership #BusinessCommunity #ProfessionalGrowth
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ISO 10993-1:2025 is published! Share this post to spread the word! Congratulation and let's the fun begin! #biocompatibility #ISO10993
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QMSphere reposted this
✅ ISO 13485:2016 has been officially reaffirmed in 2025! Big news for MedTech and Quality professionals: ISO 13485:2016 has been officially reaffirmed in 2025 following its scheduled systematic review. No revisions yet — the standard remains the cornerstone for regulatory compliance across global markets. 💡 Why it matters: With FDA’s QMSR aligning to ISO 13485 and global convergence accelerating, reaffirmation means stability for manufacturers, auditors, and regulators. 🔮 What’s next? Future revisions may introduce cybersecurity, AI, and sustainability clauses. But for now, ISO 13485:2016 stays strong. -- #ISO13485 #MedTech #QualityManagement #RegulatoryCompliance #MDSAP #FDA #QMSR #MedicalDevices #GlobalStandards #QMSphere #AI
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QMSphere was represented yesterday by Julia Schnider at the OCRA Orange County Regulatory Affairs Discussion Group event in Irvine. Events like these foster valuable exchange and innovation across the regulatory and quality community — exactly what drives our mission at QMSphere. #RegulatoryAffairs #QualityManagement #LifeSciences #Networking #ISO13485
Grateful for a fantastic day yesterday at the OCRA Orange County Regulatory Affairs Discussion Group Fall Symposium in Irvine — insightful talks, great people, and inspiring conversations!
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