— Micro-credentials for suppliers of medical technology are a modern certification instrument
They support compliance with key EU legislation, allowing conformity of medical technologies with the applicable rules to be confirmed quickly and efficiently.
They are grounded in the rules on ESG, MDR, RODO (GDPR), AI Act, AML and NIS2. Each of these regimes imposes requirements on suppliers and manufacturers of technology in respect of safety, quality, data protection and process transparency — and it is precisely this that micro-credentials attest to.
Audit and Certification Centre for the Medical Sector
Micro-credentials, as market-recognised short-form certificates, are supported by European Union rules within the European Education Area and the strategy relating to the European Qualifications Framework (EQF).
These rules enable the mutual recognition of micro-credentials across EU Member States, which increases professional mobility and allows skills and competences to be validated quickly, without the need to obtain traditional, long-cycle qualifications.
The introduction of micro-credentials for suppliers of medical technology, grounded in EU legislation such as RODO (GDPR), AI Act, AML and NIS2, is the foundation on which our certification offering rests. These micro-credentials allow the conformity of medical technologies with the key rules on data protection, cybersecurity and artificial intelligence to be confirmed quickly and transparently, which strengthens the safety of, and confidence in, medical solutions.
In the context of medical tourism, they also attest to quality in respect of patients’ rights and to the ethics and financial integrity of entities providing services in the healthcare sector.
What do we offer clients in practice?
01
Industry Certification for the Healthcare Sector
HCPL industry certification focuses on confirming that products, services and processes conform to international standards and to the legal requirements specific to the healthcare sector, including ISO, the MDR (Medical Device Regulation), the GDPR, NIS2 and ESG.
Key elements of the offering:
- Certificates of conformity with standards: HCPL certifies products and services that must meet high quality, regulatory and environmental standards. These certificates also cover ESG aspects, which carry increasing weight in public procurement.
- Conformity audit: the certification process includes comprehensive audits of conformity with sectoral and legal requirements and with ESG, aimed at securing the highest level of quality, safety and sustainability.
Benefits:
- Greater competitiveness in public tenders through demonstrated compliance with ESG standards.
- Easier fulfilment of legal requirements on data protection, cybersecurity and sustainability.
- Confirmation of conformity with the requirements of public institutions, including hospitals classified as strategic entities.
02
Micro-credentials for Specialists in the Healthcare Sector
HCPL micro-credentials are a flexible form of certification confirming specific professional competences, knowledge and skills in the operation of certified products and in conformity with legal requirements (GDPR, NIS2) and ESG principles.
Key elements of the offering:
- Training concluding with micro-credentials: HCPL provides specialist training for staff of hospitals and other healthcare institutions, allowing competences — including in ESG — to be acquired and confirmed quickly.
- CPE educational points: through our training offering, contracting authorities can obtain Continuing Professional Education points, which are required under continuing professional development programmes, including those covering ESG matters.
Benefits:
- Participation in HCPL training secures internationally recognised micro-credentials that cover ESG aspects.
- The opportunity to accumulate CPE educational points, which support professional development and conformity with sectoral and sustainability requirements.
- Confirmation of competence in conformity with the rules on data protection, cybersecurity and sustainability.
03
Training and Support for Manufacturers Certified by HCPL
HCPL offers a comprehensive training and certification process for manufacturers seeking accreditation to offer certified products in the healthcare sector, ESG aspects included. Certified manufacturers may offer training and micro-credentials to their own clients, which increases the value of the products they supply.
Key elements of the offering:
- Accreditation process: the manufacturer must obtain HCPL accreditation, which involves conformity audits and compliance with international standards (ISO, MDR, NIS2) and with ESG.
- Training for contracting authorities: certified manufacturers may run training that allows contracting authorities to obtain micro-credentials and CPE educational points.
Benefits:
- HCPL accreditation increases client confidence and opens the way to public procurement, which increasingly requires ESG compliance.
- The ability to run authorised training concluding with micro-credentials, raising the competence of clients and users of certified products, with an emphasis on sustainability.
04
Support in the Public Procurement Process
HCPL supports both contracting authorities and suppliers in preparing to take part in public procurement, with an emphasis on conformity with legal requirements (GDPR, NIS2) and with ESG, which is increasingly required in public tenders.
Key elements of the offering:
- Tender preparation: advice and support on meeting formal, technical, legal and environmental (ESG) requirements, enabling effective participation in public tenders.
- Audit and certification: HCPL provides conformity audits and certification of products, services and processes — a prerequisite for suppliers bidding for public contracts.
Benefits:
- Fulfilment of the requirements arising from the Public Procurement Act, including those on quality standards, safety and sustainability.
- A better prospect of winning a tender through certificates attesting to ESG and other regulatory compliance.
05
Audit of Conformity with Legal Requirements (GDPR, NIS2, ESG)
HCPL provides audits of conformity with key legal regimes, including the GDPR (personal data protection), NIS2 (cybersecurity) and ESG (sustainability). The service is addressed both to public and private institutions that must meet the highest standards of data protection, critical infrastructure security and social responsibility.
Key elements of the offering:
- GDPR conformity audit: a review of the personal data protection policy against the law in force.
- NIS2 conformity audit: review and analysis of IT security systems in healthcare institutions, which are key entities covered by the NIS2 regime.
- ESG conformity audit: a review of processes and procedures relating to sustainability, including environmental impact, corporate social responsibility and governance.
Benefits:
- Full conformity with legal requirements on data protection, cybersecurity and ESG.
- Reduced exposure to financial penalties, better protection of critical infrastructure and compliance with sustainability standards.
06
Consulting and Advisory Services for the Healthcare Sector
HCPL provides advisory services to hospitals, medical institutions and technology companies operating in the healthcare sector. The advice covers the implementation of quality standards, data security, and conformity with international rules and ESG standards.
Key elements of the offering:
- Advice on implementing NIS2, GDPR and ESG: support in designing and implementing procedures that conform to the law in force and to sustainability principles.
- Implementation of quality standards (ISO) and ESG: support in implementing international quality and ESG standards, which is central both to certification processes and to public procurement.
Benefits:
- Greater operational effectiveness and conformity with legal and ESG requirements.
- Better preparation for audit, certification and tender processes in public procurement.
The Healthcare Poland offering is designed to give the healthcare sector comprehensive support in meeting regulatory requirements, quality standards and sustainability (ESG) principles. The certificates and micro-credentials issued by HCPL are intended to increase competitiveness, improve the quality of services and products, and secure conformity with key legal requirements such as NIS2, the GDPR, ESG and the Public Procurement Act.
An initiative worth pursuing
The Healthcare Poland offering is designed to give the healthcare sector comprehensive support in meeting regulatory requirements, quality standards and sustainability (ESG) principles.
The certificates and micro-credentials issued by HCPL are intended to increase competitiveness, improve the quality of services and products, and secure conformity with key legal requirements such as NIS2, the GDPR, ESG and the Public Procurement Act.
01
Confirm that a technology, device or process conforms to the law — for example the GDPR
Confirm GDPR conformity in respect of the protection of patients’ personal data, which strengthens the safety of, and confidence in, their solutions.
02
Obtain certification that systems and manufactured devices conform, for example, to the AI Act in terms of risk
Obtain certification that AI systems conform to the AI Act, confirming alignment with the rules on the safe and responsible use of artificial intelligence in medicine.
03
Confirm the security of their IT systems, for example in line with the NIS2 Directive
A certificate confirming that the supplier secures its IT systems in accordance with NIS2, which strengthens protection against cyber threats and ensures conformity with the requirements of the European cybersecurity directive.
Our micro-credentials rest on audits and verification of conformity with key EU legislation, allowing suppliers to certify their products and services quickly and transparently. Certification not only eases cooperation with healthcare providers but also strengthens suppliers’ credibility and competitiveness on the European and international markets.
Meet our partners
A complete ecosystem of educational, audit and integration activity behind Healthcare Poland certificates and micro-credentials
