For medical device manufacturers, maintaining market access requires ongoing compliance with evolving regulatory requirements.
When Gynaecologic, a developer and manufacturer of anatomically designed pessaries for the treatment of pelvic organ prolapse, decided to become the legal manufacturer of its medical devices, it faced a significant regulatory and quality management challenge. After years of relying on an external manufacturing partner, the company needed to achieve MDSAP certification to support Class IIa medical device registration with the Therapeutic Goods Administration (TGA).
Working with SGS, regulatory consultants and key suppliers, Gynaecologic successfully achieved MDSAP and ISO 13485 certification, supporting its Class IIa medical device registration with the TGA and helping maintain access to the Australian market.
In this case study, you'll learn:
- What the audit revealed about Gynaecologic's quality management system
- The steps taken to achieve MDSAP and ISO 13485 certification
- The key outcomes, benefits and lessons learned
Read the full case study to discover how Gynaecologic successfully navigated its certification journey and maintained access to the Australian medical device market.
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of over 100,000 dedicated professionals. With more than 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and a portfolio of trusted specialized brands, including Applied Technical Services, Brightsight, Bluesign and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN SW).
