Medical Devices Development


Manufacturers developing new medical devices shall benefit using our QARA consulting and engineering services ensuring product compliance with applicable medical device regulatory requirements and controlled transfer to production.
Quality Management Systems


We help you to design and establish management system relevant for your organization allowing operations conduct according to documented rules, policies, procedures and instructions.
Quality and Regulatory Affairs


We investigate for you Global regulations, European directives and International standards to facilitate your organization standardization, regulated products development and market authorization.


Decades of QUALITYCERT team's experience in management systems, medical devices quality and regulatory is available at your request and customized agenda.

Medical Devices Consulting and Engineering

Expert’s services throughout entire product life cycle

Medical devices regulatory documents
Regulations, Directives, Guidelines…

Medical devices classification
Web App


It is our pleasure to introduce QualityCert Ltd., a MedTech consulting and engineering company with this web presentation.

QualityCert is providing support to various healthcare organizations and in all fields of research, design, development, production, distribution, registration and sales of healthcare products.

QualityCert is founded by the specialists with decades of experience with the international companies. It is established to provide effective support to our clients and to develop successful partnership among all parties being involved in the projects.


Nedim Junuzovic

CEO, Principal consultant

Dipl. Ing. of mechanical engineering in the field of products and manufacturing engineering. He's got 20 years of work experience solely in area of quality and regulatory affairs, wherefrom 15 years in medical devices development. His experience is based on various medical devices development projects in USA and Denmark, of which most are De Novo products. He is longtime member of ISO/BAS technical committees concerning medical devices quality and has been qualified by German’s world leading Notified Body as medical devices Lead auditor and conformity assessment expert for European regulatory framework (CE marking).

Samir Zehic

Management systems consultant

Bachelor of economics in the field of organization management. His primary occupation is based on developing and auditing management systems of healthcare organizations. Experienced with best industry practices in the field of good distribution, manufacturing, laboratory, pharmacy, transportation, warehouse and other. He’s got distinguished knowledge of quality and regulatory affairs that concerns medical devices wholesale, distribution and post- market surveillance. Samir is certified auditor of management systems and educator. Proficient in consulting and coaching within the field of expertise, as well in providing in-house and public trainings on relevant quality and regulatory topics.

Asmir Alic

Management systems consultant

Bachelor of laws and his primary work is based on search and identification of applicable regulatory framework in order to implement quality management systems. Experienced in international standards and local regulations implementation within medical devices life cycle and in particular wholesale and distribution organizations. Proficient in good distribution practices, pharmacy safety systems and general management system standard requirements. His competences referring to interpretation of the requirements. Asmir is certified quality management systems auditor.

Amera Sinanovic

Product engineering consultant

Electrical engineer in the field of Telecommunication and Information Technologies. Teaching assistant at Faculty of Electrical Engineering, University of Tuzla. Experienced in creating surface mount technology (SMT) and automated optical inspections (AOI) programs for printed circuit board assembly process and product manufacturing workflow preparation. Amera's primary work is based on research in field of data modeling and design of communication systems.

Ademir Omercehajic

Product engineering consultant

Mechatronics engineer graduated from Mechanical Faculty. His primary work is based on new concept design and medical devices development. His competencies referring to that are based on 3D modelling, electronics design and signals and data processing. Experienced in product architecture design, pressure force and vital signs electro-optical sensors. Proficient in microcontrollers programing, C and C++ program languages, as well as in mechanical and electronics design software programs.

Admir Mehmedovic

Product engineering consultant

Mechatronics engineer graduated from Mechanical Faculty. His area of expertise is embedded software development, CAD design and 3D printing. Experienced in PCB design and assembly, control electronics, digital signal processing and robot operating systems. Experienced in algorithm development, light sensors and pressure force sensors in medical devices. Proficient in C and C++ programming languages, as well as in mechanical and electronics design software programs.


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ISO Global Survey – Certification in numbers

*Organizations certified Worldwide to Management System standards
ISO 9001

916 842

ISO 13485

25 656

ISO 14001

348 473

ISO/IEC 27001

44 499


            *The ISO Survey 2020, (ref: