We’ll assist your medical laboratories and technical developers in creating a Quality Management System and certify your product and bring it to the global healthcare industry.
Be confident to enter the healthcare industry market with the ISO 13485 and/or the CE Marking certification, with a Company specializing in Medical Devices (MD) and In-Vitro Diagnostic Devices (IVD).
Hab Gov Strategics Applied Technologies Ltd.
We have more than 20 years of experience of consulting services for regulatory and clinical affairs, quality system implementation and maintenance, training and related services, as well as in country representation services, such as European Authorized Representation delivered to the medical device industry. We have delivered quality management systems and certifications for multinational companies such as: Thermo Fisher Scientific, Dako ( part of Agilent), and VWR™ (part of Avantor). Whether you are a manufacturer, importer or distributor of low, medium or high-risk products, we have the expertise to achieve market placement.
Only with an effective Quality Management System can Medical and In-Vitro Diagnostic Devices enter the marketplace. With a structured QMS we can help you qualify of the global ISO 13485 certification and the European CE Marking.
ISO 13485
The Hab Gov team will develop your internal Quality Management Systems (QMS) from scratch. To be ISO 13485 compliant means your device is certified and able to enter the global market and access new markets. To-date, the ISO covers almost every industry, from technology, to food safety, to agriculture and healthcare in 164 worldwide countries.
CE Marking
We are registered as a European Authorised Representative, certified with the Malta Competition and Consumer Affairs Authority (MCCAA). We are able to assist and meet EU directives and requirements, to achieve the CE Marking, a certification mark that is mandatory for products within the European Economic Area (EEA). We can help insure your product(s) meet EU safety, health, and environmental protection requirements.
We help achieve regulatory demands for your MD and/or IVD products, within the healthcare industry. Whether you are a manufacturer, importer or distributor of low, medium or high-risk products, we have the expertise to achieve market placement.
Medical Devices & In-Vitro Diagnostic Devices
Meeting requirements for medical device (MD) and In-Vitro Diagnostic Devices (IVD) companies can be difficult, as the approach to regulation varies from country to country. Our compliance team have the experience to navigate MD and IVD compliance in major international markets. We can help identify the regulatory requirements for your device so you can maintain regulatory compliance for devices classified as: Class A,B,C,D (Low, Medium, High). Whether you are a manufacturer, importer or distributor of MD and/or IVD products, we have the expertise to meet healthcare regulatory and safety demands so you achieve market placement.
We will help establish a Quality Management System (QMS) and set policies, processes and procedures required for Class A,B,C,D In-Vitro Diagnostic Devices to qualify for ISO 13485 and CE Marking certification.
Have more questions on what Hab Gov Strategics Applied Technologies can do for you?
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Get In Touch
Headquarters Office:
Hab Gov Strategics Group of Companies
Malta Life Sciences Park
Digital Hub, LS3,
San Gwann SGN 3000
Malta
Contact Hours: 10:00 – 12:00, 14:00 – 16:00 (CET)