We help you establish an effective, sustainable, and compliant Quality Management System (QMS). Our approach covers all phases — from analysis of the current state to the successful completion of the certification audit.
The complete process of establishing a quality management system through to obtaining internationally recognized certification.
Mapping and optimization of business processes in line with company objectives.
Preparation of the Quality Manual, Standard Operating Procedures (SOPs), and accompanying work instructions and forms.
Harmonization of manufacturing, storage, and distribution processes with the requirements of the standard and the Serbian rulebooks on the manufacture/distribution of medical devices.
Establishment of risk management (ISO 14971), process validation, sterilization validation, and supplier control.
Information security risk assessment, development of security policies, and implementation of controls to protect confidential and business data.
Identification of nonconformities and definition of an action plan.
Drafting customized procedures, instructions, and responsibility matrices.
Training employees for consistent implementation of adopted procedures.
Conducting an internal audit and resolving nonconformities before the arrival of external auditors.
Expert assistance and presence during Stage 1 and Stage 2 external audits conducted by an accredited certification body.
Our team consists of experts with many years of experience working with ALIMS, the Ministry of Health, and professional bodies in Serbia.
We reduce the risk of application rejection and shorten the time required for products to reach the market.
We provide support from the initial idea and compliance assessment, through certification and registration, to post-market surveillance.
Contact us for consultations and the preparation of an offer tailored to your business needs.