Quality Assurance

Qarad assists manufacturers in implementing their Quality Management Systems

Implement a Quality System

Regulations for In Vitro Diagnostics and Medical Devices include quality system requirements. Although ISO certification is not a requirement, EN ISO 13485:2016 is the harmonized standard for quality system requirements and ISO 13485 certification will give the manufacturer structural advantages and improve business continuity.

  • The Canadian authorities impose ISO 13485 certification by a registrar, accredited by Health Canada.
  • The MDSAP audit program (USA, Canada, Brazil, Japan, Australia) is built upon the foundations of ISO 13485.

Let us help you

Whether your quality system still has to be built from scratch or only needs minor adjustments, Qarad can define what needs to be done to implement a quality system that is compliant with applicable regulations and/or quality system standards.

We can give you the assistance that you need:

  • We perform audit-based gap analyses.
  • We organize group training sessions.
  • We provide personal guidance.
  • We write documents, such as procedures and processes.

 

By combining work in our office with on-site visits anywhere in the world, we can give you the personal approach that you need. 

Qarad can build your entire Quality Management System or make minor adjustments to improve.

We can assist with:

ISO 13485
ISO 9001
MDSAP

Qarad, a valuable partner

Qarad’s consultants have held positions in the industry in Quality Assurance, Quality Control, Regulatory Affairs and product development for more than 30 years. We have personally dealt with the problems you may encounter with the implementation of a quality system for In Vitro Diagnostics and Medical Devices.

As consultants, we have successfully assisted IVD and MD manufacturers in achieving ISO 13485 certification and CE certification. The companies we have worked with have ranged from 1 to 100 employees.

We are fluent in English, German, Dutch, French and Italian and have a passive knowledge (reading) of more languages. Therefore, we have been able to work with companies in more than 15 countries on four continents

ISO 13485 / ISO 9001

The ISO 13485 standard is based on the general requirements of ISO 9001, but it is specifically designed for quality management systems for medical devices.

Qarad’s experts can build the entire Quality Management System from scratch or we can perform gap analyses to improve your existing system.

AcroMetrix has definitely enjoyed the benefits of your knowledge and expertise with quality and regulatory issues in the EU community for several years.

Life Tech AcroMetrix, Inc.

MDSAP audits

The Medical Device Single Audit Program (MDSAP) was developed to ensure that a single audit will provide efficient yet thorough coverage of the requirements of medical devices for all participating countries.

Qarad has developed a tool to perform mock audits to verify whether you are ready for your MDSAP audit.

Thanks to the help and preparation we have received from Qarad, we have been able to successfully pass the MDSAP certification audit without any non-conformities.

Qarad IVDR Conference 2022

NHOW Brussels

October 11-13

Get the latest IVDR insights during our three-day conference, including a pre-conference workshop.