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.

 

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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.

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.

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.

ABOUT

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.

 

CERTIFICATION

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.

More About EU Regulations and Directives

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.

EXPERTISE

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.

 

SERVICES

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.

Quality Management System

HabGov will work closely with your team to extract the crucial information and translate it into an effective Quality Management System (QMS), defined in a formalized system that documents processes, procedures, and responsibilities for achieving quality policies to ultimately achieve ISO 13485 and/or CE Marking registration. Our plan is simple, structured and high-level. We define, determine and create a pre-audit requirements checklist. We are then able to form the obligations of manufacturer and departments. We collect data through clinical investigation and evaluation. We then implement a conformity assessment, that will define the obligations of the authorised representatives, importers, distributors, etc. Our team will then support, train and help implement the QMS so that registration and certification are achieved; therefore, your IVD or Medical Device successfully enters the international market.

CONTACT US

Have more questions on what Hab Gov Strategics Applied Technologies can do for you?

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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)