We can assist all companies in the medical, IVD, cosmetic and other sectors, who need support to develop and/or check their own Quality System, or that of outsourced suppliers, in compliance with the main quality system certification schemes (ISO13485, MDSAP, ISO22716, 21CFR820, ISO9001 etc.), and also in all validation activities typically required in these areas, such as Process Software Validation, Equipment Validation, Process Validation.
Quality System: Certification & Validation
Quality System
Maytal is able to support all companies in the medical, IVD, cosmetic and other sectors, which need support:- In developing its Quality System in compliance with the main quality system certification schemes (ISO13485, MDSAP, ISO22716, 21CFR820, ISO9001, etc.)
- In entrusting the audit of its Quality System to qualified and independent experts, with a focus on the elements of organizational efficiency, so that the quality system is an instrument used in daily work and not a mere formal fulfillment of an obligation
- In entrusting the audit of Quality System of external suppliers to qualified and independent personnel
- In assisting the company during the Audit by the Certification Body or the Competing Authority
Validation
Maytal is able to support the manufacturers of Medical Devices, IVD and cosmetics in all of the most typical validation activities required in these sectors, such as:- Validation of process software: software used in production processes, validation of spreadsheets, management software, etc.
- Equipment Validation: drafting of protocols (IQ, OQ, PQ) and assistance in checking the results and preparing the reports
- Process validation: drafting protocols (eg packaging, sterilization, washing, etc.) and assistance in checking the results and preparing the reports
