Accreditations and certifications

The (EFI) awards the EFI certificate to laboratories that meet the quality requirements set by EFI (Standards). EFI is a European organization focusing on immunogenetics, tissue typing, and transplantation. The EFI certificate is required by several organizations operating in the field of stem cell and solid organ transplantation including JACIE, NMDP, and the Eurotransplant foundation. The EFI Accreditation Programme provides an internationally recognized accreditation scheme for laboratories providing Histocompatibility & Immunogenetics (H&I) testing services in support of solid organ and hematopoietic stem cell transplantation, blood transfusion, disease diagnosis, and drug hypersensitivity reactions.

(GMP) define the minimum requirements that must be fulfilled by pharmaceutical manufacturers in their production processes. Compliance with these standards is essential for any company that wishes to offer its medicines for sale in the European market, regardless of location. GMP mandates that all medicines must be consistently high-quality, appropriate for their intended use, and meet the regulatory requirements outlined in marketing or clinical trial authorizations. These guidelines help to ensure that the end product is safe, effective, and of a consistently high standard.

is an independent, non-governmental international organization that develops and publishes standards to ensure the quality, safety, and efficiency of products, services, and systems.

DIN EN ISO 15189 | D-ML-21356-01-00

DIN EN ISO 15189 is an international standard for medical laboratories. It specifies the requirements for quality and competence in medical laboratory services and outlines the processes that are necessary to ensure that patient test results are reliable and accurate. The standard covers areas such as laboratory management, personnel training and qualifications, test performance, and the reporting of results. Adherence to DIN EN ISO 15189 helps to ensure that medical laboratories provide high-quality services that meet the needs of patients, healthcare providers, and regulatory agencies. The standard is regularly reviewed and updated to reflect the latest developments in medical laboratory technology and practices.

Find a list of all procedures within the scope of accreditation as a medical laboratory according to DIN EN ISO 15189 below.

Declaration under Art. 5 (5) EU Regulation on in vitro diagnostic medical devices (EU) 2017/746 (IVDR) for in-house production of IVD in healthcare institutions

Declaration under Art. 5 (5) EU Regulation on in vitro diagnostic medical devices (EU) 2017/746 (IVDR) for in-house production of IVD in healthcare institutions

CAP# 8035600 | AU-ID: 1637475

is the world’s largest organization of board-certified pathologists and the leading provider of laboratory accreditation and proficiency testing programs. The accreditation process, a two-year accreditation cycle, includes on-site inspection, desk review, and optional education modules and gap assessment – designed to ensure the highest standard of patient care and application of best practice.

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The verifies that a device meets all regulatory requirements for in-vitro diagnostic medical devices to be freely sold in the European Economic Area.

is an independent, non-governmental international organization that develops and publishes standards to ensure the quality, safety, and efficiency of products, services, and systems.

ISO 13485

ISO 13485 provides a comprehensive framework for medical device manufacturers to ensure product quality and regulatory compliance. The primary objective of the ISO 13485 certification process is to ensure medical devices consistently meet customer needs and applicable regulatory requirements.

ISO 15189

ISO 15189 specifies requirements for quality and competence in medical laboratories. It is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.

ISO 9001

ISO 9001 specifies requirements for a quality management system when an organization:

a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All the requirements of ISO 9001 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

ISO 27001

ISO/IEC 27001 is the international standard for establishing, implementing, maintaining and continually improving an Information Security Management System (ISMS). It provides a structured, risk based framework to protect the confidentiality, integrity and availability of information across people, processes and technology, supporting effective information security governance and risk management.

The , as the national accreditation body of Greece in accordance with the Law 4468/2017, accredits the Diagnostic Laboratory “MEDICOVER GENETICS S.A.” in Athens, Greece under the terms of the ELOT EN ISO 15189:2022 Standard and the ESYD Criteria, to carry out tests, as specified in the attached Scope of the Accreditation, which may be revised by decisions of ESYD.

Provision of primary healthcare services: Integrated services for the implementation and diagnosis of laboratory genetic, genomic and cytogenetic tests and preimplantation testing PGT.

Granting of an operating license for a Preimplantation Genetic Testing Laboratory.