LATEST NEWS
Transition to ISO17025 Accreditation
or laboratories operating in regulated industries, including biotechnology, therapeutic goods, and medical devices, achieving ISO17025 accreditation enhances credibility, supports regulatory complianc... ...more
ISO 17025
March 11, 2026•5 min read
From Lab Results to Defensible Evidence
Transforming laboratory results into defensible evidence requires rigorous adherence to quality systems, data integrity principles, and regulatory compliance standards. By implementing structured proc... ...more
Compliance
March 10, 2026•5 min read
Risk Management and ISO14971
ISO14971 provides a structured, scientifically rigorous framework for managing risk across the medical device lifecycle. Integration with ISO13485 quality systems ensures comprehensive coverage of des... ...more
ISO 14971
March 04, 2026•5 min read
ISO13485 Transition Support A Case Study
The transition to updated ISO13485 requirements represents a complex undertaking for medical device manufacturers, particularly when products involve both physical diagnostic components and software s... ...more
ISO13485 Certification
March 02, 2026•7 min read
Decision-Making Under Uncertainty
Decision-making under uncertainty is a defining challenge for therapeutic goods startups. Companies must determine when to validate, submit, or scale manufacturing while balancing quality requirements... ...more
Leadership Values ,Medtech
February 26, 2026•5 min read
TGA Compliance Principles 2026 and 2027
The TGA Compliance Principles 2026 and 2027 provide a structured, risk-based framework for monitoring, enforcing, and supporting compliance with the Therapeutic Goods Act 1989. ...more
Therapeutic Goods Administration ,Compliance
February 22, 2026•5 min read
A High-Level Guide to Electronic Records and Signatures
A high-level understanding of 21 CFR Part 11 enables companies to navigate the complexities of electronic data management effectively, demonstrating compliance and fostering trust with regulators, par... ...more
Procedures and Policies ,Leadership Values
February 18, 2026•5 min read
Data Integrity Fundamentals and ALCOA(+/++) Principles
By applying these scientific and regulatory standards consistently, organizations can foster a culture of accountability, reliability, and excellence—ensuring that every piece of data serves its inten... ...more
Quality Culture
February 15, 2026•6 min read
From Chaos to Control: Transform Regulatory Ambiguity into Market Strategy
By transforming chaos into control, businesses can leverage regulatory compliance as a tool for market differentiation, operational excellence, and sustainable growth ...more
Leadership Values ,Compliance
February 09, 2026•5 min read
A Case Study of Providing GMP Support to a Wholesaler of Radiopharmaceuticals
This case study demonstrates the critical importance of GMP support for wholesalers of radiopharmaceuticals. By partnering with Quality Systems Now, the client was able to implement comprehensive qual... ...more
Quality Training ,GMP
February 08, 2026•5 min read
QSN Isn’t Just External Support — It’s Capability Building That Stays With the Company
Investing in QSN’s capability-building approach transforms compliance from a temporary activity into a sustainable organisational strength, reinforcing quality culture, reducing risk, and enabling lon... ...more
QMS ,Compliance
February 04, 2026•5 min read
TGA Compliance Principles 2026–2027: A Proactive and Risk-Based Approach
The TGA Compliance Principles for 2026 and 2027 reflect a proactive, risk-based approach to safeguarding public health through the regulation of therapeutic goods. ...more
News
February 03, 2026•5 min read
Achieving Organizational Discipline Around Quality Records
Achieving organizational discipline around quality records is a scientific and systematic endeavor that extends across regulatory, operational, and cultural dimensions. ...more
Procedures and Policies ,Quality Culture
January 29, 2026•5 min read
From Design Controls to Clinical Evidence
From design controls to clinical evidence, the development of therapeutic goods is a continuous, interconnected process grounded in scientific discipline and regulatory compliance. ...more
Quality Culture
January 27, 2026•6 min read
Operational Knowledge Gaps
Quality Systems Now provides more than external support — it builds capability within startups, embedding regulatory, quality, and operational knowledge. By implementing structured QMS, regulatory pre... ...more
Leadership Values
January 22, 2026•4 min read
Funding & Investor Expectations
For therapeutic goods, biotechnology, and medical device startups, securing funding is not simply a matter of demonstrating innovative science. Investors require evidence of robust governance, clear r... ...more
News
January 20, 2026•4 min read
Establishing a Robust Quality Management System (QMS)
For therapeutic goods, biotechnology, and medical device startups, a robust QMS is essential for regulatory compliance, operational efficiency, and investor confidence. Early-stage companies often und... ...more
QMS
January 15, 2026•5 min read
Regulatory Complexity & Compliance Burden
Regulatory complexity and compliance burden are inherent challenges in the therapeutic goods and biotechnology sectors. Startups must contend with fragmented, technical, and constantly evolving global... ...more
Compliance
January 13, 2026•4 min read
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