Build a quality system that works with your team.

Keren worked closely with our Sequencing Hub for several years as a Quality Management System (QMS) consultant, providing expert guidance throughout the successful transition of our accreditation for whole genome sequencing whilst ensuring our QMS remained practical, robust, and compliant. She played a key role in educating and refreshing our team on quality management principles, preparing us for external accreditation audits, and providing invaluable support before and during the audit process. Her knowledge, attention to detail, and calm, pragmatic approach gave our team confidence and contributed significantly to successful accreditation outcomes.

I have had the pleasure of working with Keren from SmartQMS during the early stages of developing a medical device, and I can confidently say she has been exceptional.

Her communication is clear, responsive, and practical, which is invaluable when navigating the complexity of medical device standards and regulatory requirements. She has a deep understanding of regulation and compliance, and is able to translate these requirements into actionable steps for founders.

What truly differentiates Keren is her ability to understand the stage and strategy of a startup. She provides guidance that is proportionate, risk-based, and aligned with commercial reality, ensuring compliance is built properly from the outset without unnecessary overengineering. For early-stage MedTech founders, that balance is incredibly valuable.

I would highly recommend Keren and SmartQMS to any medical device startup seeking expert, pragmatic support in building a quality system and preparing for compliance.

Keren has been our Quality Manager at the Recombinant Products Facility for the past four years, and we’re incredibly grateful for her strategic guidance. Thanks to her leadership, we smoothly achieved ISO 9001 certification in 2022, and we’ve just passed our fourth audit with no findings for the fourth consecutive time!

What truly sets Keren apart is her people-centric approach. Rather than providing a one-size-fits-all template, she helped us develop a quality management system tailored to our unique needs. She went to great lengths to educate our team on the value of working within ISO standards, fostering a culture of quality awareness and continuous improvement.

Keren instilled a strong sense of ownership by empowering us to build a system that’s both simple and flexible, allowing it to evolve over time. Her approach to making the quality system work for the people who use it is refreshing — with Keren, quality management is not a bureaucratic hurdle but a strategic asset. She has transformed our approach, making the quality system a tool that supports our goals rather than something we simply comply with.

Keren joined the Ramaciotti Centre for Genomics as a consultant when we started the process of working towards accreditation for key genomic applications. She provided expert guidance on how to approach the regulator and how to implement a QMS in what at the time was a core facility supporting a very broad range of research across the country. She prepared the lab team for the task ahead and prepared myself and the managers for the shift in thinking that is required as you move towards accreditation.

Keren’s calm, considered and ordered approach, expertise and experience in all things quality, and excellent communication skills make her a trusted colleague and advisor. Her unique skillset was invaluable, and under her guidance the Centre successfully obtained and maintained its ISO/IEC 17025 accreditation.

Keren has consistently demonstrated outstanding leadership as our Quality Manager at the Ramaciotti Centre for Genomics over the course of several years. She played a crucial role in steering us through the ISO/IEC 17025 accreditation process, overseeing the implementation of necessary procedures, and has continued to flawlessly manage our Quality Assurance system. Her impressive skill set and unwavering dedication make her a true standout leader. If anyone needs guidance and leadership going through NATA or other accreditation, I would recommend you contact Keren!

I can’t recommend Keren highly enough for her guidance in helping the UNSW RNA Institute become the first ISO 9001 certified RNA therapeutics manufacturer in Australia. Her knowledge of the QMS and certification landscape, excellent communication, and organised, pragmatic approach was invaluable. What could have been an overwhelming task was instead a manageable and rewarding effort in which we achieved our certification goals within an ambitious timeline. From the initial discussion as to which ISO certification best suited our needs, through to the final audit and follow-up, her advice and direction were critical to our success.