Comprehensive services in medical devices regulation and quality of healthcare products
Expert advice to medical device manufacturers and operators, offering comprehensive support to ensure compliance with applicable regulations, excellence in quality, and regulatory robustness throughout the entire product lifecycle.
EAA Med Consulting has a clear vision: to make regulation more accessible, strategic and effective.
Every great product starts with a solid regulatory strategy.
We support you with rigour, proximity and strategy
EAA Med Consulting was created with the aim of helping companies comply with regulations and transform that compliance into an opportunity for growth. The team is led by Elena Aramburu Andrés, a biomedical engineer with over ten years of experience in medical device regulation and quality.
At EAA Med Consulting, we believe that regulation can be managed clearly and strategically. With knowledge, planning and collaboration, every project can achieve commercial success.
Solutions offered to help you move forward
Quality Systems (ISO 13485)
Implementation and maintenance of quality management systems in accordance with ISO 13485, ensuring efficient processes that comply with applicable requirements.
Medical Devices – European Regulation (MDR)
Full regulatory support for CE marking of medical devices in accordance with Regulation (EU) 2017/745 (MDR). Comprehensive coverage of medical devices of any class and technology, including hardware, software, legacy products, and those covered by Annex XVI.
In Vitro Diagnostic Medical Devices – European Regulation (IVDR)
Through a network of specialized collaborators, EAA Med Consulting provides full regulatory support for IVD products, aligned with Regulation (EU) 2017/746 (IVDR).
International Markets
Regulatory and strategic support for market expansion beyond the European Union, adapting documentation and processes to meet country-specific requirements.
Tailored Consulting
Tailored consultancy, adaptable to the needs of each project, ideal for technical or regulatory support at key moments.
Why Choose Us
- Over 10 years of experience in the healthcare and medical device industry.
- Personalized and flexible approach adapted to each company’s needs.
- Direct and transparent collaboration.
- Clear deliverables aligned with the expectations of Notified Bodies..
- Experience with startups, SMEs, and established manufacturers.
Do you have any questions? Contact us!
Please do not hesitate to contact us for any enquiries, collaborations or new projects.
- info@eaamedconsulting.com
- Spain – Online services available