LATEST NEWS
Case Study SaMD and IVD Medical Device Start-Up
This case study illustrates how targeted ISO 13485 support can enable a SaMD and IVD medical device start-up to establish robust, compliant quality systems and achieve audit readiness. ...more
Medtech
January 07, 2026•5 min read
Can you help with our next audit or inspection?
Can you help with our next audit or inspection? Absolutely. Quality Systems Now offers audit readiness reviews, mock inspections, and audit response assistance to support organisations through every s... ...more
Audit Readiness
January 04, 2026•5 min read
Pharmaceutical Quality Management Systems for the Future
The future of pharmaceutical Quality Management Systems lies at the intersection of regulatory rigor, technological innovation, and organizational excellence. ...more
QMS
January 02, 2026•5 min read
Happy New Year 2026: A MedTech Perspective on Innovation and Compliance
May 2026 be a year of innovation, regulatory excellence, and continued progress in improving patient outcomes worldwide. ...more
News
December 31, 2025•4 min read
Validation Gaps That Kill Launch Timelines
Validation is a critical component of quality management that ensures medical devices are safe, effective, and compliant. For MedTech innovators, gaps in validation ...more
Quality Culture
December 25, 2025•5 min read
Fast Track to ISO 13485 for MedTech Innovators
With the support of GMP and regulatory compliance specialists like Quality Systems Now, organizations can navigate the complexities of ISO 13485 implementation, ensuring both compliance and business s... ...more
ISO13485 Certification
December 22, 2025•5 min read
Season’s Greetings and Merry Christmas from Quality Systems Now
From everyone at Quality Systems Now, we wish you a Merry Christmas and a positive start to the New Year. Thank you for your continued engagement, professionalism, and commitment to quality and compli... ...more
News
December 17, 2025•4 min read
The Role of Compliance in Product Development
Product development compliance is an essential scientific discipline that underpins successful innovation in regulated industries. ...more
Compliance
December 15, 2025•5 min read
Clarifying and Strengthening the Regulation of Medical Device Software Including Artificial Intelligence (AI)
The regulator’s mid-2025 review acknowledges that the existing, technology-agnostic, risk-based framework remains fundamentally appropriate for SaMD and AI-enabled medical devices ...more
News
December 10, 2025•5 min read
Case Study: QMS Gap Assessment and Integration
The QMS gap assessment and integration project demonstrated how systematic evaluation, scientific documentation practices, and targeted training can achieve compliance with PIC/S PE 009 and Annex 3 re... ...more
Quality Culture
December 08, 2025•6 min read
ISO Accreditation Readiness Scorecard
GMP licensing and ISO accreditation are critical milestones for therapeutic goods manufacturers, testing laboratories, and biotechnology companies. A readiness assessment using a structured scorecard ... ...more
ISO Recommendations
December 03, 2025•4 min read
AusBiotech 2025 International Conference
AusBiotech 2025 offered a valuable reflection point for the biotechnology sector, particularly regarding GMP and regulatory compliance. ...more
News ,GMP
December 01, 2025•3 min read
Think You're Ready for Your Next GMP Inspection?
Preparing for a GMP inspection requires a comprehensive, structured approach encompassing quality management systems, documentation, facilities, equipment, personnel, process control, and risk managem... ...more
GMP
November 27, 2025•4 min read
Establishing Readiness for Clinical Trial Manufacturing
Establishing readiness for clinical trial manufacturing is a multidimensional process requiring attention to regulatory compliance, facility and personnel preparedness, quality systems, process valida... ...more
Medtech
November 24, 2025•5 min read
Is Your Warehouse Process Designed for GMP or ISO Compliance?
Warehousing is a critical component of the supply chain for therapeutic goods, biotechnology products, and laboratory materials. ...more
GMP
November 19, 2025•6 min read
What is the Difference Between R&D Documentation and GMP Documentation?
The regulatory environment surrounding R&D documentation is generally less stringent than that governing GMP documentation. ...more
GMP
November 17, 2025•5 min read
QMS Gap Assessment and Integration
The QMS gap assessment and integration conducted by QSN demonstrates a comprehensive approach to achieving regulatory compliance in the therapeutic goods sector. ...more
QMS
November 10, 2025•5 min read
GMP Certification Milestones & Global Inspection Activity
GMP certification milestones and global inspection activity are more than regulatory formalities; they represent critical mechanisms for ensuring product quality, patient safety, and corporate credibi... ...more
GMP
November 05, 2025•6 min read
Temporary GMP Exemptions for Bacteriophage Therapies in Australia
The proposed temporary GMP exemption by the TGA for personalised bacteriophage therapy manufacture in Australia marks a significant regulatory development for the emerging phage‑therapy sector. ...more
News
November 02, 2025•6 min read
Case Study: Supporting a Manufacturer Transitioning to ISO 13485 Compliance
This case study demonstrates how Quality Systems Now provides end-to-end support for manufacturers transitioning into medical device production. By combining standards expertise, practical implementat... ...more
Compliance
October 29, 2025•4 min read
New Regulations to Strengthen Medical Device Patient Safety
The introduction of mandatory reporting requirements for medical device-related adverse events marks a significant step forward in enhancing patient safety in Australia. ...more
News
October 26, 2025•4 min read
Understanding the Gaps and Overlaps Between ISO 13485, EU MDR, and MDSAP
ISO 13485, EU MDR, and MDSAP share significant commonalities in quality management, risk control, post-market surveillance, and documentation practices. However, gaps remain in clinical evaluation, UD... ...more
ISO13485 Certification
October 22, 2025•6 min read
General GxP Requirements – GLP, GCP, and GMP
GLP, GCP, and GMP form the backbone of GxP requirements in the life sciences sector. While each framework has a distinct focus—laboratory studies, clinical trials, and manufacturing—they share core pr... ...more
GMP
October 18, 2025•5 min read