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Medical Device Consulting

Medical devices

Expert Guidance

in Regulatory Compliance for Medical Devices

The medical device sector operates under a strict regulatory framework to ensure the safety, quality, and effectiveness of every product brought to market. Regulatory compliance is not only mandatory but crucial for the commercial success of any medical device.

With over 20 years of experience in digital solutions, quality management, and regulatory compliance, our consulting firm offers comprehensive support for manufacturers, importers, and distributors of medical devices. We provide the technical and regulatory expertise needed to accelerate market access in Europe.

From product classification to CE marking, we guide our clients through the entire regulatory process in compliance with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), including:

  •  Implementation and auditing of quality management systems under ISO 13485 
  • Preparation of technical documentation and product dossiers
  • Clinical evaluation and risk management
  • Market strategy and labeling compliance with MDR/IVDR
  • Adaptation to regulatory changes and European legislative updates

Additionally, we integrate digital solutions tailored to the regulated environment, optimizing documentation processes, traceability, and product lifecycle management, fully aligned with quality and compliance principles.

If your company is developing a new medical device or needs to adapt to the latest regulatory requirements, we can help. Our multidisciplinary team offers tailored solutions to ensure compliance and facilitate successful market access.

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Medical Devices classification and regulation

Every medical device must meet specific regulatory requirements before entering the market. We determine the correct classification under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic devices.

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Implantación de Sistemas de Gestión de Calidad ISO 13485

ISO 13485 certification is essential for medical device manufacturers. We assist in implementing an efficient, compliant quality management system (QMS).

Transition from MDD/IVDD to MDR/IVDR

We support companies in transitioning from previous directives to the new MDR and IVDR regulations, ensuring full regulatory compliance.

CE Marking for Medical Devices

CE marking is mandatory for marketing any medical device in Europe. We prepare technical files, clinical evaluations, and regulatory submissions to meet all requirements.

AInternational Market Access: FDA & MDSAP

We assist in certifying medical devices for international markets, including the U.S. (FDA), Canada, Australia, and Japan through the MDSAP program.

PRODUCTS

PRODUCTS

eQMS
eQMS
(Electronic Quality Management System)

A digital platform to manage regulatory compliance and quality processes for medical devices.

ARI
ARI
(Automated Regulatory Intelligence)

Stay informed of regulatory changes in the medical device sector.

QMSuite
QMSuite

Templates for implementing and managing Quality Management Systems (QMS) and regulatory processes.

AReIA
AReIA

Your customized compliance manager with task assignment and tracking features for regulatory activities.

Consulting Services

Consulting Services

Gap Analysis

Comprehensive review of activities and processes to identify non-conformities and implement corrective actions.

Internal Audits

Specialized audits to verify compliance with ISO 13485, MDR, and other applicable regulations.

Due Diligence

Pre-acquisition audits and investigations to assess regulatory compliance status before contractual agreements.

Regulatory & Clinical Strategy

Development of regulatory strategies for market entry, ensuring international compliance.

RaaSdesk (Regulatory Affairs as a Service)

Ongoing regulatory consulting service to maintain compliance.