Case Study: Supporting a Manufacturer Transitioning to ISO 13485 Compliance

Case Study: Supporting a Manufacturer Transitioning to ISO 13485 Compliance

Quality Systems Now
Published on: 29/10/2025

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 implementation, personnel training, and audit support, QSN ensured the company was fully prepared for regulatory inspection and compliant operations.

Compliance
Compliance Isn’t a Cost Center, It’s Your Launch Strategy

Compliance Isn’t a Cost Center, It’s Your Launch Strategy

Quality Systems Now
Published on: 12/10/2025

When you’re ready to scale or license your innovation, buyers and investors want one thing: regulatory assurance.

Compliance
A Startup’s Guide to Regulatory and Commercial Readiness

A Startup’s Guide to Regulatory and Commercial Readiness

Quality Systems Now
Published on: 05/10/2025

For many startups, the steepest learning curve lies not in the innovation itself—but in understanding and meeting the rigorous expectations of regulators such as the Therapeutic Goods Administration (TGA)

Compliance
Complying with ALCOA++ Principles

Complying with ALCOA++ Principles

Quality Systems Now
Published on: 10/09/2025

Complying with ALCOA++ Principles

Quality CultureCompliance