MEDICAL DEVICE & IVD COMPLIANCE
We provide regulatory support to comply with the below directives and regulations:
- EU: Directive 93/42/EC and MDR 2017/745 on medical devices
- EU: Directive 98/79/EC and IVDR 2017/746 on in vitro diagnostic medical devices
- USA: FDA 21 CFR parts: 820, 809, 822 and part 349 over the counter drugs
- Canada: Canadian Medical Devices Regulation SOR 98-282 and NNHPR, SOR/2003-196 (Natural Health Products)
- Australia: TGA ARGMD (Medical Devices)
- Singapore: HSA GN-01 (Medical Devices)
- Brazil: INMETRO and ANVISA's regulatory requirements
ABOUT US
Helping Companies Successfully Transition from Innovation to Regulated Healthcare and Product Safety
Founded in 2009, TOX Regulatory Advisor ApS is an independent consultancy specialising in Regulatory Affairs, Clinical Affairs, Quality Management and Toxicology.
For more than 15 years, we have supported organisations across the medical device, in vitro diagnostic (IVD), pharmaceutical, chemical and cosmetic sectors in navigating complex regulatory, scientific and quality requirements throughout the entire product lifecycle.
Our expertise spans Europe, North America, Asia, Latin America, Africa and the BRICS countries, supporting organisations from early product development through regulatory approval, market access and post-market activities.
As healthcare continues to evolve through Artificial Intelligence (AI), connected technologies and digital health solutions, regulatory expectations are evolving as well.
Today, our expertise has expanded to support organisations developing AI-enabled medical devices and Software as a Medical Device (SaMD), helping bridge the requirements of the EU Medical Device Regulation (EU MDR 2017/745), the EU Artificial Intelligence Act (EU AI Act 2024/1689) and the General Data Protection Regulation (GDPR).
Successfully bringing AI-enabled medical devices to market requires more than software development alone. It requires the integration of regulatory affairs, quality management, risk management, design controls, validation, clinical affairs, human factors, data governance and lifecycle management into a coherent development strategy.
At Tox Regulatory Advisor, we help organisations bridge these technical, clinical and regulatory requirements to support the development of safe, effective and compliant healthcare products.
Alongside our expertise in AI-enabled medical devices, we continue to support manufacturers of medical devices, IVDs, pharmaceuticals, chemicals and cosmetic products through practical scientific, regulatory and quality solutions tailored to their business needs.
Our Areas of Expertise
AI-Enabled Medical Devices & Digital Health
Supporting software companies, digital health innovators and MedTech manufacturers with:
EU AI Act implementation and AI Medical Device Readiness
Regulatory Strategy and AI Risk Management
Clinical Validation, Human Factors & Usability Engineering &AI Governance
Design Controls & Design Assurance
Post-Market Surveillance, Quality Management Systems & Technical Documentation
Executive Advisory, Workshops and Team Training
Medical Devices & In Vitro Diagnostics (IVDs)
Supporting manufacturers throughout the product lifecycle with:
Regulatory Affairs, Clinical Affairs and Biological evaluation/biocompatibility
Design Controls & Design Assurance
Design Verification & Validation
Risk Management & Technical Documentation
Quality Management Systems & Post-Market Support
Standards Compliance & Global Market Access
Pharmaceuticals, Chemicals & Toxicology
Supporting organisations with:
Toxicological Risk Assessment and Chemical Regulatory Compliance
Scientific and Regulatory Strategy &Product Stewardship
Safety Documentation &Regulatory Support
Cosmetic Safety & Product Development
Helping organisations develop safe, effective and compliant cosmetic products through:
Cosmetic Formulation, Cosmetic Safety Assessments &Toxicological Risk Assessment
Ingredient Evaluation, Regulatory Compliance & Product Development Support
Our Approach
Our role extends beyond helping organisations comply with regulations.
We help our clients make informed development decisions by integrating science, engineering, clinical thinking, quality management and regulatory strategy from the earliest stages of product development through market access and lifecycle management.
Whether supporting AI-enabled medical devices, medical devices, IVDs, pharmaceuticals, chemicals or cosmetic products, our objective remains the same:
Helping organisations reduce regulatory uncertainty, strengthen product development and bring safe, effective and compliant products to market with confidence.
Turning innovation into products prepared for regulated healthcare and global markets.