Consultation on
Software Regulatory
Affairs

Software Regulatory and Privacy affairs
are our everyday business!

Any software which is used as standalone medical product or as part of a medical product, should be developed under specific regulatory framework.

Our specialists will help you understand, implement and conform to regulatory requirements. Through our guidance, you will turn your idea into a certified software.

Expertise

Our team consists of quality & security specialists with extensive experience in:

ISO 13485
Medical devices Quality System
MDR
Medical Device Regulation
IVDR
In-Vitro Diagnostics Medical Device Regulation
21 CFR Part 820
Quality System Regulation - FDA
IEC 62304
Medical device software
ISO 14971
Risk management
IEC 62366-1
Usability engineering
IEC 82304
Health software
IEC 60601
Safety (PEMS)
HIPPA
Security & Privacy Rules
GDPR
General Data Protection Regulation
Cybersecurity (FDA)
Guidelines on Cybersecurity

Contact Us

Repadο

Repado is a certified software development house specialized in the Life Science and Healthcare Industry.

With more than 20 years’ experience in the MedTech field, we provide Software Development and Consultation services for regulated environments (MDR/IVDR).

The company is certified under ISO13485:2016 with primary objective the facilitation of harmonized medical device regulatory requirements for Quality Management Systems and ISO9001:2015 Certification for Software development and Implementation.

email: info@repado.com

Headquarters

Switzerland // Kreuzstrasse 100, 8645 Rapperswil
p. +41 55 210 11 10

Subsidiary

Greece // K. Varnali 13 Str., 15233 Athens
p. +30 210 68 38 406
REGISTRATION:007836501000

Consultation on Software Regulatory Affairs

Software Regulatory and Privacy affairs are our everyday business!

Expertise

ISO 13485

MDR

IVDR

21 CFR Part 820

IEC 62304

ISO 14971

IEC 62366-1

IEC 82304

IEC 60601

HIPPA

GDPR

Cybersecurity (FDA)