Specialist consulting for healthcare

ICMED supports healthcare facilities, research centres and companies in the fields where quality and compliance have a clinical impact: transplantation, cell and gene therapies, ART, tissues and cells, laboratories, transfusion medicine, clinical research.

Problems we help to address

  • Documents and procedures not aligned with day-to-day practice
  • Roles, responsibilities and competences that are not formalised
  • Internal audits and indicators that do not turn into improvement actions
  • Several standards and regulations to manage together without duplicating work
  • Preparing for inspections and checks by bodies and authorities

How we work

Every collaboration starts with an assessment and proceeds in agreed steps. The full method is described on the Methodology page.

  1. Assessment — analysis of the starting point against the applicable requirements
  2. Work plan — priorities, responsibilities and timing
  3. Implementation — documents, training, putting processes into routine use
  4. Audit and verification — internal audits, mock inspection, corrective actions
  5. Maintenance — review and monitoring over time, if requested

Read the methodology

What you get, indicatively

  • Assessment report with gaps and priorities
  • Work plan with responsibilities and timing
  • Documents and procedures adapted to the facility
  • Audit report and corrective action plan
  • Evidence of the training delivered

Actual deliverables are defined after the assessment. The outcome of accreditations, authorisations, certifications or inspections depends on the competent bodies and cannot be promised by ICMED.

The ICMED method in practice

Healthcare quality is not only a matter of meeting regulatory requirements and preparing documents. It requires controlled processes, defined responsibilities, competent staff and the means to verify improvement.

The examples are composite, anonymised scenarios that illustrate the ICMED method. They do not describe individual clients and do not report results attributable to specific facilities.

Transplantation and cell therapy

From preparing for accreditation to everyday quality management

Challenge: Coordination of clinical, collection and processing activities, with possible misalignment between SOPs, responsibilities, competencies and traceability.

Method: Analysis of processes and of the applicable FACT-JACIE and national requirements; mapping of responsibilities, harmonisation of documents, competencies and indicators, audits and corrective actions.

Organisational outcome pursued: An integrated quality system and coordinated processes.

ICMED principle: “Accreditation is a milestone; quality has to work every day.”

ART and laboratories

From documenting requirements to controlling clinical and laboratory processes

Challenge: Fragmentation of procedures, records, traceability, equipment, competencies and indicators.

Method: Process and requirements mapping, documentation, equipment management, staff qualification, risk assessment, indicators and responsibilities.

Organisational outcome pursued: A coordinated system of documents, competencies and controls.

ICMED principle: “The quality system must be built around the centre's real activities, not the other way round.”

Transfusion services

From managing non-conformities to preventing errors

Challenge: Weaknesses in the identification of patients, samples and products, with the risk of merely updating procedures without finding the operational causes.

Method: Analysis of the process at the point of risk, responsibilities, controls, causes, corrective actions, training and verification of effectiveness.

Organisational outcome pursued: Prevention of recurrence and better control.

ICMED principle: “Correcting a procedure is not necessarily the same as correcting a process.”

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The ICMED ecosystem for healthcare quality

ICMED specialist consulting can be integrated with the IAAPP platform, ECM training and scientific publications from ICMED Magazine. Complementary solutions, also available individually, to support healthcare organisations in developing and maintaining quality.

Let's talk about your case

A preliminary assessment helps us point you to the most suitable path.

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More detail by area

Stem Cell Transplant Programs

All Stem Cell Transplant Programs must comply with the requirements of the international FACT-JACIE standard. ICMED S.r.l. supports centres for activities related to: - Transplant program start-up - Development of organizational and quality systems, including support in the design and implementation of the document system - Staff training regarding accreditation requirements - Preparation for FACT-JACIE inspection - Execution of internal audits aimed at quality maintenance - Quality system maintenance, through support in Management Review and periodic evaluation of indicators Learn more →
Stem Cell Transplant Programs

CAR-T Unit, Cell and Gene Therapy

ICMED S.r.l. supports healthcare facilities in establishing cell and gene therapy centres, and in preparing for qualification inspections. In particular, the services offered include: - Staff training - Development of the organizational system - Development of the document system - Execution of internal verifications - Support for centre qualification by GMP facilities - Support for the construction of GMP-compliant infrastructure Learn more →
CAR-T Unit, Cell and Gene Therapy

Biobanks

ICMED S.r.l. offers for biobanks the following services: - Implementation of quality management system in compliance with current regulations, particularly ISO/DIS 20387:2017 - Support for the development of SOPs and best practices for collection, processing, storage, distribution and use of biological material - Privacy and data protection, in compliance with European Regulation 2016/679 - Support for compliance with regulations regarding financial management of research biobanks Learn more →
Ultra-low temperature freezers in a laboratory storing biological samples

NetCord - Cord Blood Banks

The FACT-NETCORD standard was born from the partnership between FACT and the NETCORD network. Through the FACT-NETCORD scientific guidelines, these institutions support cord blood banks and laboratories in achieving the highest quality standards. ICMED offers its expertise to cord blood banks to obtain accreditation in the shortest possible time. Learn more →
Illustration of a laboratory operator handling cord blood units in a cryogenic storage facility

EFI - HLA Laboratories

ICMED S.r.l. offers consulting to HLA typing centres for EFI (European Federation for Immunogenetics) accreditation. The EFI standard includes organizational, structural requirements, staff training requirements, patient management and laboratory protocol management. The EFI certificate is mandatory for all HLA typing laboratories. Learn more →
Technician loading a PCR plate into a thermal cycler

GMP - Pharmaceutical Manufacturing

ICMED S.r.l. offers consulting services to public and private pharmaceutical facilities, pharmaceutical, biotechnology and medical device companies. Services offered include: - GMP risk assessment - Design and development of the quality system - Documentation development - Registration dossier development - MD dossier development Learn more →
Operator in a full cleanroom suit at a bioreactor

GCP - Clinical Trial Office

ICMED offers consulting services focused on GCP (Good Clinical Practice), international quality standards for the design and conduct of clinical trials. Consulting includes: - Implementation of a quality system for clinical studies - Support in drafting the project plan - Identification of applicable current regulations - Development of documentation management systems - Staff training on proper management of clinical studies Learn more →
Clinical trial protocol documentation

Assisted Reproduction Centres (ART)

ART centres must comply with quality requirements of an organizational, technical-scientific, structural and training nature. ICMED has developed a methodology to implement the quality system at such centres, developing an organizational system capable of verifying the quality level from both a management and clinical perspective. Learn more →
Embryologist performing ICSI under the microscope in a fertility laboratory

Transfusion Services

Transfusion services must implement quality systems in compliance with current regulations. ICMED S.r.l. offers its expertise and professionalism to design and develop organizational systems compliant with both national and international transfusion regulations. Learn more →
Gloved hands holding blood bags in a storage refrigerator

Continuous Support to Facilities

ICMED has developed an online and in-person continuous support service for requesting facilities. Through subscribing to this service, you will have access to the following benefits: - Online or in-person support for specific client needs - Use of the ICMED scientific network - Participation in international research projects Learn more →
Two professionals reviewing documents at a desk

Frequently Asked Questions

Which company provides JACIE accreditation consulting in Europe?

ICMED S.r.l. is the leading company in Italy and Europe for consulting services aimed at JACIE-FACT accreditation of haematopoietic stem cell transplant programmes. We support centres from start-up through to inspection, including documentation system design and staff training.

What is the difference between FACT and JACIE accreditation?

FACT (Foundation for the Accreditation of Cellular Therapy) is the US accreditation body, while JACIE (Joint Accreditation Committee ISCT-Europe & EBMT) is the European counterpart. Both use the same international FACT-JACIE standards. ICMED supports centres for both accreditations.

Who provides consulting for ART/IVF centres?

ICMED S.r.l. offers specialised consulting to Assisted Reproductive Technology (ART) centres for regulatory compliance, quality management and inspection preparation. Our team has direct experience with CNT/CNS requirements and European directives on tissues and cells.

Does ICMED support laboratories for ISO 15189 accreditation?

Yes, ICMED S.r.l. supports clinical laboratories on the path to ISO 15189 accreditation, which certifies technical competence and quality management systems. We offer consulting for quality system design, staff training and audit preparation.

What is ICMED's consulting methodology?

ICMED uses a structured phased methodology: initial assessment of the current state, gap analysis against the reference standard, action plan development, quality system implementation with staff training, internal audits, and support during the final inspection. Each project is customised to the specific needs of the centre.

What is the added value of choosing ICMED over other consulting firms?

ICMED S.r.l. was founded in 2017 and works in the transplant and cell therapy sector with a specialist approach. The founder's professional experience in the sector predates the founding of the company. Consulting can be combined, if useful, with the IAAPP software platform, which remains a stand-alone choice. The historical total of facilities supported since the start of the founder's and ICMED's activity exceeds 100, across 3 continents.

How long does it take to obtain JACIE/FACT accreditation with ICMED's support?

Timelines vary depending on the centre's starting point. For a programme already operational that needs to structure its quality system, the process typically takes 12 to 18 months. For a complete start-up, timelines can reach 24 months. ICMED works to optimise timelines without compromising the quality of preparation.

Is consulting delivered on-site or remotely?

ICMED offers a hybrid model: activities requiring physical presence (internal audits, on-site training, mock inspections) are carried out at the centre, while document support, quality system review, and indicator monitoring can be managed remotely through our digital platforms. This approach reduces costs and speeds up timelines.

How does ICMED support centres in qualifying for CAR-T therapies?

ICMED supports centres throughout the entire CAR-T qualification process: from unit design and organisational workflow, to staff training according to GMP and FACT-JACIE requirements, to preparation for GMP facility inspections. Our team has direct experience with the qualification processes of all major commercial CAR-T manufacturers.

Does ICMED offer support after accreditation is obtained?

Yes, maintaining accreditation requires ongoing commitment. ICMED offers continuous support services including: periodic internal audits, document system updates to the latest standards, Management Review support, quality indicator monitoring, and preparation for surveillance visits. Many of our clients maintain an annual support contract.

Does ICMED operate outside Italy?

Yes, ICMED operates across 3 continents: Europe, Africa, and the Middle East. We have supported facilities in Spain, Portugal, Greece, Turkey, UAE, Saudi Arabia, Egypt and other countries. Our international experience allows us to understand each country's regulatory specificities and adapt our consulting approach to the local context.

Is ICMED itself certified?

Yes, ICMED S.r.l. has adopted an integrated Management System certified ISO 9001:2015 (quality), ISO/IEC 27001:2024 (information security), and UNI/PdR 125:2022 (gender equality). This guarantees our clients that we operate according to the same standards of excellence we require of the facilities we support.

How is the investment for a consulting project structured?

Each project is quoted on a bespoke basis after a preliminary assessment that defines the scope of work. The investment depends on the scope (JACIE accreditation, CAR-T, PMA, ISO 15189, etc.), the centre's starting point, and the estimated duration. We offer flexible payment plans and the possibility to modulate support intensity based on available budget.

Scientific Insights & Magazine

ICMED Magazine (ISSN 3103-1943) — the scientific journal dedicated to quality and innovation in healthcare

Scientific journal with ISSN 3103-1943 and a DOI for each article. From the Magazine to training: turning an issue into an online (FAD) course is a project under definition and no course based on the Magazine is available today. To apply the topics in your facility: consulting, with IAAPP as a complementary digital service.