Services
Advice to companies, offering comprehensive support to ensure compliance, quality and confidence at every stage of the product.
Quality Systems (ISO 13485)
Implementation and maintenance of quality management systems in accordance with ISO 13485, ensuring efficient processes that comply with applicable requirements.
Services include:
- Implementation and maintenance of Quality Management Systems under ISO 13485.
- Internal audits.
- Preparation and support during audits with Notified Bodies (NB) and competent authorities.
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.
Services include:
- Product classification and determination of the applicable regulatory route.
- Identification and application of harmonised standards and relevant technical regulations.
- Preparation and maintenance of technical documentation.
- Development of clinical evaluation documentation (CEP, CER).
- Development of post-market surveillance documentation (PMS, PSUR, PMCF).
- Compliance with and justification of General Safety and Performance Requirements (GSPR).
- Risk management in accordance with ISO 14971.
- Development of software documentation (IEC 62304), including the assessment of the applicability of artificial intelligence, cybersecurity and other relevant technical standards.
- Accompaniment and support in audits and regulatory review processes.
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).
Services include:
- Preparation and maintenance of Technical Documentation under IVDR.
- Definition of regulatory strategy and product classification.
- Development of performance evaluation and post-market surveillance documentation.
International Markets
Regulatory and strategic support for market expansion beyond the European Union, adapting documentation and processes to meet country-specific requirements.
Services include:
- Identification of applicable regulatory requirements and definition of market access strategy.
- Support with local representatives or authorized agents in the target country.
- For the U.S. market, regulatory guidance for Pre-Submissions, 510(k), and De Novo applications in accordance with FDA requirements.
- Assistance with document adaptation and regulatory compliance for UK and Latin American markets.
Tailored Consulting
Tailored consultancy, adaptable to the needs of each project, ideal for technical or regulatory support at key moments.
Modalidades:
- Review of technical or clinical documentation.
- Support during audits, inspections, or responses to NC reports.
- Regulatory and strategic advice for launches, modifications, or market expansion.
- Customized training sessions for regulatory and quality teams.
