Auditing

Independent internal, supplier, or certification audits conducted by auditors certified for following standards:

ISO 13485 Medical Devices

21 CFR 820 FDA Medical Devices

European MDD/ MDR

ISO 9001 Quality Systems

European GMP EudraLex - Volume 4

ISO 15378 Primary packaging Pharmaceuticals 

European GDP

21 CFR 210/ 211 FDA Pharmaceuticals

ICH Q7 Active Pharmaceutical Ingredients

ISO 22716 Cosmetics GMP

FDA Mock audit

MDSAP (Medical Device Single Audit Program) Audit

Consultancy

in following areas:

Implementation of quality systems ISO 13485, ISO 9001 and GMP

GAP analysis for standards ISO 13485, ISO 9001 and GMP

Certification of quality systems ISO 13485 and ISO 9001

Preparation for certification and supplier audits

Specific consultancy for Medical Devices:

Cleanroom and sterilization

Preparation of Technical file

Laboratory testing, clinical evaluation and studies

Registration SÚKL a FDA

Legal services

Training

by trainers with 15+ years practice in areas of:

ISO 13485 Medical Devices

21 CFR 820 FDA Medical Devices

ISO 15378 Primary packaging Pharmaceuticals 

ISO 22716 Cosmetics GMP

European GMP EudraLex - Volume 4

ISO 9001 Quality Systems

ISO 19011 Auditing

ISO 14971 Risk Management

Cleanroom and sterilization (ETO, Gamma, X-ray, E-beam, Steam)

MDD/ MDR