MEDICAL DEVICE CONSULTANCY

I am a medical device regulatory and quality consultant with extensive experience supporting manufacturers, importers, distributors, start-ups and healthcare technology companies in bringing compliant medical devices and in vitro diagnostic devices to the European and Spanish markets.

My work covers the full regulatory lifecycle of a medical device, from the initial definition of the regulatory strategy, intended purpose and classification through to CE marking, market access and post-market activities.

I provide specialised support in compliance with Regulation (EU) 2017/745 on medical devices (MDR), Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), ISO 13485 quality management systems and the specific national requirements applicable in Spain.

A key area of my expertise is obtaining and maintaining operating licences from the Spanish Agency of Medicines and Medical Devices (AEMPS). I support companies throughout the complete licensing process, particularly for medical device manufacturing and importation activities.

This includes assessing the applicable licence scope, defining the authorised activities and product categories, preparing the required quality system and technical documentation, reviewing facilities and organisational responsibilities, supporting the appointment of the Technical Responsible Person, preparing the application and responding to AEMPS requests or inspection findings.

I also advise companies on modifications, extensions and renewals of existing licences, changes in facilities or authorised activities, subcontracted operations, sterilisation and packaging activities, product grouping or system and procedure pack activities, and compliance with the obligations applicable after the licence has been granted.

My main areas of expertise include:

• Regulatory strategy and medical device classification
• CE marking and conformity assessment planning
• Preparation and review of technical documentation
• Compliance with the General Safety and Performance Requirements
• Clinical evaluation and performance evaluation
• Biological evaluation and biocompatibility strategies
• Risk management in accordance with ISO 14971
• Software medical device lifecycle and validation
• Usability engineering and cybersecurity requirements
• Post-market surveillance, PMCF, vigilance and incident management
• Implementation, maintenance and auditing of ISO 13485 quality management systems
• Support during Notified Body audits and competent authority inspections
• AEMPS operating licences for medical device manufacturing and importation activities
• Modifications, extensions and maintenance of existing AEMPS licences
• Spanish regulatory requirements for manufacturers, importers and distributors
• EUDAMED registration, UDI and economic operator obligations
• Regulatory and quality training for medical device organisations

I work closely with each organisation to translate complex European and Spanish regulatory requirements into practical, proportionate and clearly documented strategies.

My objective is not only to achieve CE marking or obtain the required AEMPS licence, but also to establish robust and sustainable processes that support product safety, regulatory compliance, market access and long-term business development.

Through AMConsulting Medical Devices, I provide tailored regulatory consulting, quality assurance, auditing, training, licensing and technical documentation services, adapting the level of support to the characteristics, maturity and specific needs of each company and medical device.