About.
Since 2012, A. Quality|Regulatory Consultancy Firm has been helping many pharmaceutical and medical device companies overcome regulatory and quality hurdles.
A. Quality | Regulatory is a Quality and Regulatory consultancy firm dedicated to helping organizations build, strengthen, and maintain effective Quality Management Systems. Since 2012, our team has been developing practical, customizable, and cost-effective QMS solutions designed to meet the unique needs of small and medium-sized businesses.
Our approach combines regulatory expertise with innovative technology to deliver streamlined QMS solutions with advanced functionality comparable to sophisticated, multi-million-dollar electronic Quality Management Systems (e-QMS). By incorporating semi-automated processes and AI-enabled technologies, we help organizations reduce administrative burden, improve efficiency, and maintain greater control over their quality and regulatory activities.
Our QMS solutions have been rigorously tested and evaluated through third-party audits and regulatory inspections, including assessments conducted under ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), the European Union Medical Device Regulation (EU MDR), and Health Canada's Drug Establishment Licence (DEL) requirements. The systems have consistently demonstrated their ability to meet rigorous regulatory expectations while remaining intuitive, practical, and easy to use.
Our mission is to make quality and regulatory compliance more accessible and manageable for growing organizations. We bring the knowledge, experience, and tools needed to help businesses establish a strong regulatory foundation—allowing entrepreneurs and leadership teams to focus on innovation, growth, and building a successful business.
In 2025, we expanded our capabilities through a growing network of strategic partners across the industry. This enables us to provide more than Quality and Regulatory consulting—we can also connect our clients with trusted expertise and resources for business setup, trademarks and patents, manufacturing, repair and service operations, sales, distribution, and international market expansion.
Whether you are establishing your first Quality Management System, preparing for a regulatory audit, expanding into new markets, or looking to scale your business, A. Quality | Regulatory is here to help.
Let us help you turn regulatory complexity into a foundation for growth. Contact us today to discover how we can support your organization.
Let’s build your path to success.
Our Management Team
Meet our experienced team of Quality and Regulatory professionals. We bring deep industry expertise, current regulatory insight, and practical strategies to help organizations navigate complexity, achieve compliance, and build a foundation for sustainable success.
Partner
Regulatory & Quality
Claire Wang brings over four years of experience in regulatory affairs and quality management within the medical device industry. With a forward-thinking approach to compliance and operational excellence, she has helped lead the company into a new era of digital transformation by implementing scalable electronic Quality Management Systems (eQMS) and integrating AI-driven resources to modernize traditional quality and regulatory practices.
Claire has successfully supported numerous clients through regulatory submissions, audit preparation, and quality system improvements across multiple global markets. Her collaborative and detail-oriented approach has helped organizations strengthen compliance, improve efficiency, and achieve successful audit outcomes with confidence.
She is recognized for combining technical regulatory expertise with innovative solutions that help companies adapt to the evolving healthcare and medical device landscape.
Claire is qualified to perform Internal Audits for the following schemes:
ISO 13485:2016
MDSAP (all jurisdictions)
EU MDR 2017/745
Partner
Design Engineer
Jayden Chinn brings a multidisciplinary engineering background to quality and regulatory work, with experience across the medical device and advanced manufacturing industries. This combination of technical training and hands-on quality experience allows him to approach regulatory requirements with an understanding of both the product and the processes behind it.
With a strong interest in practical problem-solving, Jayden applies technical analysis and an engineering mindset to complex quality challenges. His experience across engineering, manufacturing, and quality functions has shaped an approach centered on understanding underlying issues, identifying opportunities for improvement, and developing solutions that are both practical and sustainable.
Jayden holds a Bachelor of Applied Science in Nanotechnology Engineering from the University of Waterloo, with a specialization in Nanobiosystems. His education combined engineering, science, and applied research, helping shape the analytical and systems-oriented perspective he brings to complex technical problems.
Jayden currently is the lead engineer spearheading our sister company and will soon be qualified as an Internal Auditor for the following schemes:
ISO 9001:2026 Quality Management Systems
ISO 27001:2022 Information security, cybersecurity and privacy protection — Information security management systems
Connect with him today!
Our Strategic Partners
We collaborate with trusted strategic partners to expand our reach, strengthen our capabilities, and create new opportunities for growth. Through these partnerships, we connect complementary expertise and resources to deliver greater value to our clients and the organizations we serve.
Consultant
Clinical and Scientific Affairs
Mamta Khurana is a strategic clinical and regulatory consultant with 15 years of experience helping healthcare and medical device companies navigate complex clinical evidence, regulatory, and product development challenges.
She works with organizations across the product lifecycle to develop practical, evidence-based strategies that connect clinical requirements, regulatory expectations, product claims, and business objectives. Her expertise includes clinical evidence strategy, claims substantiation, clinical evaluation, evidence sufficiency assessments, benefit-risk assessment, systematic literature reviews, and regulatory clinical documentation.
Mamta has supported a diverse portfolio of Class I, IIa, IIb, and III medical devices, including implantable and interventional technologies, oncology and ablation systems, embolic and biopsy devices, treatment-planning software, and drug-device combination products. Her therapeutic experience includes interventional oncology, endoscopy, cardiology, and electrophysiology.
With experience across EU MDR, FDA, and Health Canada regulatory frameworks, Mamta helps clients anticipate evidence and regulatory needs, identify gaps, and translate complex clinical and scientific requirements into clear, defensible strategies.
Her approach is collaborative and solutions-oriented, enabling clients to make informed decisions, strengthen their clinical and regulatory position, and move products forward with greater clarity and confidence.
Connect with Mamta to discuss your clinical evidence strategy, regulatory needs, product claims, or product development and post-market evidence requirements.
Connect with her today!
Consultant
Sales and Marketing
Moe ElDeib is our sales and marketing partner who owns Accumedics Systems Inc. and have extensive relationships with healthcare professionals in North America, and the Middle East.
Moe spearheads our sales team and marketing initiatives with clients; helping them see the potential of their products in the market, bringing in strong logistics and distribution channels.
Together with A.Quality|Regulatory; we have our logistics and distribution pathways covered.
Connect with him today!