CERTIFICATIONS AND APPROVALS

ISO 9001: 2015

We have implemented a quality management system that promotes everyone’s implication and contribution in our performances’ continuous improvement. In this respect, the head management is entirely implied in the quality approach.

It belongs to the process pilots, helped by their collaborators and the Steering Committee, to keep this approach alive and to pass information enabling us to evaluate our performances and the relevance of the implemented actions. We then implement corrective actions in order to always improve the quality.

Daily quality management is the job of the Quality Manager supported by the process pilots and the quality referents of each affiliate.

We ask each of the Company’s employee to strive daily to make sure our clients are satisfied and thus secure the development and future of DERMSCAN.

AUTORISATIONS FOR BIOMEDICAL RESEARCH

We have the approval, being an authorized Research location, to carry-out biomedical researches for drugs, external medical devices, cosmetics and nutrition products.

We also have been authorized by the “Agence Régionale de Santé Rhône-Alpes” to carry-out biomedical researches (2014-0091 decree dated January 10, 2014).

APPROVALS AND GOOD LABORATORY PRACTICES

EC REGUATION COMPLIANCE

The tolerance tests are  in compliance with the new European Parliament and Council Regulation (EC) Nb. 1223/2009 dated November 30, 2009 related to cosmetic products.

APPROVAL UNDER THE RESEARCH TAX CREDIT

MEETING THE REGULATION THAT GOVERNS CLINICAL TRIALS

Clinical Good Practices (CGP) ICH Topic E6 (R2)/ Note for guidance on Good Clinical Practice- CPMP / ICH / 135 / 95, November 2016

ISO 14155: 2011: Clinical investigation of medical devices for human – Good clinical practices

Regulation (EU) No 536/2014 relating to clinical trials of medicinal products for human use (repealing Directive 2001/20 / EC).

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of November 30th, 2009 on cosmetic products (recast).

Commission Regulation (EU) No 655/2013 of July 10th, 2013 laying down common criteria for the justification of claims used in relation to cosmetic products

World Medical Association Declaration of Helsinki/ Ethical Principles for Medical Research Involving Human Subjects- Helsinki Declaration (1964) and its successive updates.

VOUNTEER DATA PROTECTION, CONFIDENTIALITY AND INTEGRITY

Regulation (EU) No 2016/679 of the European Parliament and of the Council of April 27th, 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)

« Data Confidentiality Act »: Nb. 78-17 law dated January 6, 1978 modified and updated by law Nb. 2018-493 dated June 20th, 2018.

MR-001: Reference methodology relating to the processing of personal data implemented in the context of research in the field of health with the consent of the person concerned
MR-003: Reference methodology relating to the processing of personal data implemented in the context of research in the field of health that does not require the consent of the data subject.
MR-004: Reference methodology relating to the processing of personal data implemented in the context of non-human research, studies and evaluations in the field of health.

Law n° 2012-300 of March 5th, 2012 relating to investigations involving human being.

Decree No. 2017-884 of May 9th, 2017 amending certain regulatory provisions relating to investigations involving human being.