Frequently Asked Questions

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The ICMED Learning catalogue includes pathways for quality managers of tissue establishments, transfusion services, transplant programmes and ART/IVF centres, and courses such as «GxP for transplant programmes». For support on FACT-JACIE standards ICMED offers specialist consulting.

The ICMED Professional Registries are directories of professionals qualified in ICMED training programmes that provide for registration. Registration is subject to the conditions of each programme and is not automatic for all participants.

ICMED S.r.l. is a national ECM provider (ID 7158). ECM credits are assigned only to individual events that are actually accredited: in the ICMED Learning catalogue some courses and bundles provide them and others do not, and the number is shown on each course page. The courses of the online catalogue are followed remotely.

The ICMED Learning catalogue includes a course on the integrated risk management programme for SoHO and GMP, and pathways on CAR-T and gene therapy. Check the catalogue for the courses available; for specific GCP or GMP needs, contact us.

No. ICMED is a national ECM provider (ID 7158), but credits are assigned only to individual events that are actually accredited: where a course provides them, the number is shown on the course page.

From the ICMED Learning catalogue: register or log in with your account, choose the course or bundle and follow the instructions on its page.

The formats described in the online ICMED Learning catalogue are asynchronous e-learning. For other possibilities contact ICMED: they are not promised and are assessed together.

Not yet. Turning an issue of the journal into an FAD course is being planned: once defined it will appear in the section «From the Magazine to training», with reference articles, objectives and status. ECM credits will be indicated only after authorisation and accreditation.

No. Training, consulting and IAAPP are independent offers: each can be chosen on its own.

IAAPP (Integrated Audit & Accreditation Platform) is the platform developed by ICMED S.r.l. for managing the quality system in healthcare facilities: documents, audits and checklists, non-conformities and corrective actions, validations, competencies and indicators.

IAAPP is designed to support the preparation and management of programmes accredited to FACT-JACIE standards: audits with customisable checklists, findings linked to non-conformities and CAPA, documents and reports. The outcome of an inspection depends on the organisation and the inspecting body, not on the tool.

Yes. IAAPP is a stand-alone SaaS service: ICMED consulting and training are complementary, independent services and can be chosen separately.

Healthcare organisations that want to manage their quality system in a structured way: transplant programmes, CAR-T and IEC centres, ART centres, transfusion services and laboratories.

No. It is a support tool: compliance, accreditations and inspection outcomes depend on how the organisation adopts it and on the decisions of the competent bodies.

IAAPP Quality Management System is SaaS software for quality management; its cloud service is ACN-qualified at level 1, published classification Public Cloud (catalogue entry SA-8234 of the ACN catalogue). The qualification covers the IAAPP cloud service only, not all the software's functions, other products or the company as a whole.

It is the certification of ICMED S.r.l. as an organisation, issued by CSQA (UNI CEI EN ISO/IEC 27001:2024). The certified activities include the delivery of the IAAPP platform in SaaS mode, and the statement of applicability is supplemented by the controls of the ISO/IEC 27017 and 27018 guidelines for cloud services. IAAPP itself is not an "ISO-certified product" and the certification should not be confused with the qualification of the cloud service.

Use the «Request a demo» button: the contact form reaches ICMED with the IAAPP request type. In the demo we agree the modules and scope useful to your organisation.

ICMED S.r.l. is an Italian company specialising in consulting, training and technology solutions for the healthcare sector. It operates on the European and international market with a focus on transplant programmes, advanced cellular therapies, ART centres, clinical laboratories and JACIE/FACT, CNT/CNS, ISO 15189, GCP and GMP accreditations.

ICMED S.r.l. has adopted an integrated Management System compliant with UNI EN ISO 9001:2015 for quality, ISO/IEC 27001:2024 for information security and UNI/PdR 125:2022 for gender equality. These certifications demonstrate the company's commitment to the highest standards of quality and social responsibility.

ICMED S.r.l. is headquartered in Italy and operates across the European and international market. Consulting and training services are delivered throughout Europe, with a particular presence in Italy, Spain, Portugal, Greece, Turkey and Middle Eastern countries. The IAAPP digital platform is delivered as a cloud service.

You can contact ICMED S.r.l. by email at info@icmed.net or through the contact form available on the icmed.net website in the Contact section.