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.

EDUCATION

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

Medical Device Quality and Regulatory Affairs

consulting throughout the entire product life cycle!

ABOUT US

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.

SERVICES

MANAGEMENT SYSTEMS

We help you to design and establish management system allowing your organization to perform according to following documented rules, policies, procedures and instructions.

Management System standards

• ISO9001 Quality Management Systems
• ISO14001 Environmental Management Systems
• ISO13485 Medical devices – Quality management systems
• US FDA 21CFR 820 Quality System Regulation (cGMP)
• Good Distribution Practice (GDP)
• Good Clinical Practice (GCP)
• Healthcare, Pharmaceutical and pharmacy systems;

QUALITY AND REGULATORY AFFAIRS

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

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…

AUDITING

On behalf of the Organization and on your request, we can perform various Quality auditing activities that provide a clear insight into the status of different subjects and processes , such as:

EDUCATION

Throughout project implementation or per you request we deliver trainings to your Organization, and some of those are:
Quality Management Systems, Internal auditor, Product lifecycle, New product development, CE marking, Medical Device design and development…

BENEFITS

OF REGULATED MANAGEMENT SYSTEMS AND MEDICAL DEVICES

Throughout the partnership with QualityCert, become one of many high class organizations which have established Quality Management Systems and CE marked their medical devices, where based on their feedback start experiencing benefits such as:

30% Reduction in customer claims,
95% improvement in delivery time,
40% reduction in product realization cycle time,

and more benefits related to…

Organization

Promoting of safety, reliability and quality in health care products and services,
Higher customer satisfaction levels and increasing customer demands,
International acceptance and recognition, and facilitated trade in international markets,
Manage Organization´s growth more effectively by controlling processes and resources,
Greater employee awareness (improved communications, morale and job satisfaction),
Supplier advanced controls to capture effectively non-conforming deliveries,
Create effective system and continual improvement culture;

Product

Organization demonstrate controls of design and development of medical device,
Acceptable device registration with regulated product design and established QMS,
Risk based thinking to foresee system and product failures,
Reduced Lab compliance testing failure rate due to non-conforming product design,
Regulatory compliance maintained by day to day operations in safe and effective way;

ISO Global Survey – Certification in numbers

*Organizations certified Worldwide to Management System standards

ISO 9001

1 058 504

certificates

ISO 13485

31 520

certificates

ISO 14001

362 610

certificates

ISO/IEC 27001

39 501

certificates

*The ISO Survey 2017, (ref: www.iso.org)

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.

EDUCATION

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

Medical Device Quality and Regulatory Affairs

consulting throughout the entire product life cycle!

ABOUT US

SERVICES

Naslov

MANAGEMENT SYSTEMS

Management System standards

QUALITY AND REGULATORY AFFAIRS

MEDICAL DEVICES DEVELOPMENT

AUDITING

EDUCATION

BENEFITS

OF REGULATED MANAGEMENT SYSTEMS AND MEDICAL DEVICES

Organization

Product

ISO Global Survey – Certification in numbers

*Organizations certified Worldwide to Management System standards

ISO 9001

1 058 504

certificates

ISO 13485

31 520

certificates

ISO 14001

362 610

certificates

ISO/IEC 27001

39 501

certificates

OUR REFERENCES