Research

Reference centre for 'Boutique-services' and expert consultancy on complex medical device studies

CMCiB's expertise is to offer 'boutique-services' for complex projects under high quality standards.

The certified surgical facilities & services, available advanced biomaging technologies and the experience and close interaction of the CMCiB team with international Key Opinion Leaders and scientists of the Catalan Health and Research systems provide excellent opportunities for collaborations in R&D, especially for the development of new technologies, therapies or medical devices.

CMCiB has an extensive track-record in the validation of medical devices in large animal models, offering services for proof-of-concept or functional studies, either acute or chronic, for implants, surgical sutures, stents, muscular electrostimulation devices, endovascular devices or techniques such as Transcatheter Aortic Valve Implantation (TAVI) procedures for research institutions and medtech companies worldwide.

CMCiB has an extensive track-record in the validation of medical devices in large animal models, offering services for proof-of-concept or functional studies, either acute or chronic, for implants, surgical sutures, stents, muscular electrostimulation devices, endovascular devices or techniques such as Transcatheter Aortic Valve Implantation (TAVI) procedures for research institutions and medtech companies worldwide.

GLP Medical device studies at CMCiB

Good Laboratory Practices (GLP) are the highest quality standard that CMCiB offers to its clients in the pharmaceutical and medtech sectors, ensuring that data obtained during product validation trials are reliable, reproducible, and auditable, following international criteria recognised by regulatory agencies. The reaccreditation of the centre and obtaining the GLP compliance certificate underscore the trajectory and quality of CMCiB's services for medical device validation and the goal of achieving excellence in research and translating results into clinical practice.

With this regulatory milestone, the CMCiB consolidates itself as one of the few national public research centres with GLP certification specialised in the validation of medical devices (registration code BPL059CAT) and strictly adheres to international research standards for preclinical studies. The animal care and welfare program, professional training, documentation of the studies conducted, and the facilities and equipment of the advanced surgical area, as well as the animal housing facilities, have been inspected for the renewal of its certification. These spaces and equipment include highly equipped operating rooms, and imaging technologies such as ultrasound, magnetic resonance imaging, and interventional vascular radiology.

The official certification document, granted by the Generalitat de Catalunya, assures the excellence and reliability of the results obtained in the validation studies conducted at the centre. It also represents CMCiB's commitment to international quality criteria in translational research.

The facilities hold the Certificate of assessment of conformity with GLP according to Directive 2004/9/CE, issued by the Subdirectorate-General for Healthcare and Pharmaceutical Planning and Quality of the Government of Catalonia, which is the competent control authority in the application of GLP principles in drugs, cosmetics and medical devices in Catalonia, in accordance with the Royal decree 2043/1994.

CMCiB adheres to the Good Laboratory Practice Principles set out by the Royal Decree 822/19932 in areas necessary for the validation of medical devices' efficacy, biocompatibility, and tolerance:

  • Analytical and clinical chemistry testing (8*):
  • Biochemistry
  • Hematology
  • Other studies (9)*:
  • Dosing of test substance and specimen drawing
  • Biocompatibility of medical devices

To achieve this accreditation, CMCiB has a team of professional experts who serve as study directors and GLP quality technicians, with the support of the  Quality Assurance (QA) Unit, comprised by an in-house CMCiB QA officer and external QA consultants.

CMCiB also complies with other International Quality Standards (ISO 10993-2:2006, ISO 10993-6, and ISO 10993-4).

Since 2021, it has been required by law that medical products, such as prostheses, catheters, valves, stents, and surgical devices, be preclinically validated according to GLP standards. A study protocol, meticulous documentation of the work performed, and a final report of results are necessary for regulatory agencies to authorize the use of the new product in clinical trials and for its subsequent commercialization.

Since its first GLP certification the surgical area has registered more than 50 studies for public research organizations and international companies, more than a quarter of which have been conducted for industrial clients under GLP conditions.

CMCiB facilities renewed its certificate of compliance with Good Laboratory Practices (GLP) in accordance with Directive 2004/9/EC in October 2023.

This achievement contributes to consolidating CMCiB as a tool for transferring research and innovation to society and improving the healthcare system and people's health through new medical solutions reaching the market.

GLP Validation Studies of Embolizing Products from iVascular and the Rob Surgical Robot

Since the centre's inception, the advanced surgery team has been involved in development and functional validation projects for a wide range of medical devices in various therapeutic areas and for different indications, such as prostheses, catheters, valves, stents, embolizing fluids, biodegradable implants, etc., which have been fundamental in achieving the experience and establishing the quality and demanding system required for GLP certification. During the first accreditation period, the centre marked a significant advance by incorporating its first GLP studies for medtech clients.

The company iVascular, founded in 2010 in Barcelona with the aim of developing medical devices and therapies for the treatment of vascular system disorders, has been a key client in the development of the first GLP studies at CMCiB, contributing to building a portfolio of projects and a trajectory of multiple safety, efficacy, and technical viability studies in a porcine model with some of its embolizing products. In its pipeline, iVascular has a wide range of coronary, peripheral, and neurointerventional products with solid scientific evidence within its iVasTriam clinical trials program, demonstrating the efficacy and safety of the products.

In anticipation of the upcoming clinical transition of the products tested at CMCiB, training workshops have been conducted and promoted by the company to specialists in interventional radiology at the CMCiB facilities. From the GLP studies conducted at CMCiB and the products tested, specifically, one of them has already progressed to human clinical trials, following international Good Clinical Practice (GCP) standards. CMCiB has contributed to the preclinical trials of the Rob Surgical Bitrack, a robotic system that has successfully completed the second series of surgeries with patients at the Hospital Clínic and is still in the final phase of European certification, being the first surgical robot conceived and developed in Catalonia. These advances have positioned CMCiB as a benchmark in technological transfer and medical innovation.

More information on Medical device Success stories.

Good Laboratory Practices (GLP)

Good Laboratory Practices (GLP) constitute a quality framework that regulates how research laboratories organize and conduct non-clinical studies focused on the health and environmental safety of various substances and chemicals. This quality framework establishes standards for planning, conducting, monitoring, documenting, and storing these studies, essential for the homologation and/or approval of chemicals intended for human and veterinary use, including medicines, cosmetics, healthcare products, pesticides, phytosanitary products, food additives for human and animal consumption, and industrial chemicals.

Since 1995, in Catalonia, the responsibility for ensuring adherence to GLP principles for studies related to the health and environmental safety of drugs and healthcare products, according to the guidelines of the Organisation for Economic Co-operation and Development (OECD) and the European Union, lies with the Department of Health of the Generalitat de Catalunya, more specifically the Pharmaceutical Control and Healthcare Products Service of the Directorate General for Healthcare Regulation.

CMCiB adheres to the criteria defined by Royal Decree 822/19932 in conducting preclinical studies on healthcare products, incorporating analytical evaluations and clinical chemistry (hematology and biochemistry) in the dosing studies of test products and sample collection, as well as the biocompatibility study of healthcare products.