About Lisora
We remove complexity from ISO certification so businesses grow with confidence.
Who We Are
A team of qualified ISO specialists, lead auditors and assessors dedicated to making certification simple, reliable and effective across global markets.
Expert ISO Team
Lisora's ISO experts simplify certification with practical, effective solutions helping your business grow with confidence and global credibility.
Innovative Certification Platform
A trusted international ISO standards provider delivering reliable, professional solutions so businesses achieve recognised certification with ease.
Global Client Reach
Serving industries worldwide, built on years of trusted expertise, strong leadership and a deeply respected professional reputation.
End-to-End Support
From gap analysis to final certificate, our professionals handle everything under the highest global standards for a seamless, stress-free process.
Vigorous Quality
Lisora came into existence in 2022 as a result of the pressing need for a more streamlined approach to regulatory processes that meet ISO standards. As technology progressed, a radical new era of quality communication emerged alongside it.
The standards and policies integrated to advance information security and the quality of our processes have given us an extra edge in service delivery. "Vigorous" stands as our defining word and slogan. We also provide expert Regulatory Affairs (RA) services — including MDSAP, MDR, FDA, TGA, PRRC, and MHRA compliance — helping businesses meet global regulatory requirements with confidence.
Navigating the Path to
ISO Certification
ISO certification is a mark of quality and efficiency, boosting credibility and competitiveness for businesses of all sizes. This guide explores the certification process and how Lisora supports you every step of the way.
Understanding ISO Certification
ISO (International Organisation for Standardisation) sets global standards to ensure quality, safety and efficiency in products, services and processes.
The ISO Certification Process
Achieving ISO certification is a systematic and structured process that involves several stages including documentation, implementation, audits and continuous improvement.
The Role of Lisora
Lisora guides you through every step, making the process smooth and efficient. Partnering with Lisora helps streamline certification, boost your business reputation and achieve excellence.
Navigating Global
Regulatory Compliance
Regulatory Affairs services ensure your business meets international compliance requirements. Lisora supports you across all major global regulatory frameworks with expert guidance.
Medical Device Single Audit Program
A single audit accepted by multiple regulatory authorities including USA, Canada, Brazil, Australia and Japan — reducing audit burden for medical device manufacturers.
Medical Device Regulation
EU Medical Device Regulation compliance covering risk management, quality management systems, post-market surveillance and CE marking requirements.
Food & Drug Administration
US FDA compliance for medical devices, pharmaceuticals and food products — covering 510(k), PMA submissions, quality system regulations and facility registration.
Therapeutic Goods Administration
Australian TGA compliance for therapeutic goods including medical devices and medicines — covering registration, listing and inclusion in the Australian Register of Therapeutic Goods.
Person Responsible for Regulatory Compliance
EU MDR/IVDR mandated PRRC services ensuring a qualified person oversees regulatory compliance, post-market surveillance and conformity of your medical devices.
Medicines & Healthcare Products Regulatory Agency
UK MHRA compliance for medicines and medical devices post-Brexit — covering UKCA marking, clinical investigations and registration on the MHRA database.
Guide to ISO & RA Services
A detailed roadmap covering both ISO Certification and Regulatory Affairs — from preparation and documentation to audits, submissions and final approval.