QMS/ISO Certification Support

We pride ourselves on staying abreast of regulatory requirements and industry best practices, ensuring that your Quality Management Systems (QMS) is robust and effective.
We assist in identifying QMS gaps at any stage, support with audits, and offer digital transformation solutions that includes assistance with establishing a QMS from scratch, evaluating your current QMS against relevant standards, or performing both activities in tandem. We are well-equipped to provide comprehensive support for your QMS, regardless of their stage of implementation. Our team of experts is fully prepared to identify and address any gaps that may exist within your QMS, using a range of services

Additionally, we can take care of the assessment of your QMS feasibility for obtaining the required certification, e.g., ISO 13485/9001.

We customize our Quality Management System (QMS) support services to cater to the specific requirements of diverse industries:

Medical devices / IVDs manufacturers, distributors, importers, and authorized representatives who require an ISO 13485/9001 compliant QMS.
Good Manufacturing Practice (GMP) certification for pharmaceuticals manufacturers.
ISO 22716 compliance for cosmeceuticals manufacturers.
GMP for food supplements manufacturers, as outlined by the European Commission in Regulation (EC) No 2002/2006.

If you plan to achieve compliance for a specific procedure of your Quality Management System (QMS), we offer expertise in various areas:

Risk Management (ISO 14971)
Clinical Evaluation and Investigation (ISO 14155/ICH GCP)
Software Life Cycle Process (IEC 62304),
Application of Usability Engineering to Medical Devices (IEC 62366)
Safety and Essential Performance Standards for Medical Electrical Equipment (IEC 62366).

Our team of experts can provide tailored solutions to help you achieve compliance with the applicable standards for your product or device.

The scope of our services covers support with both internal and external audits (Virtual & Remote) to ensure that your QMS is functioning optimally and in compliance with regulatory standards.
Additionally, we offer the capability to modernize and streamline your existing QMS into eQMS or create eQMS for you from scratch. The digital innovation can improve the overall efficiency and effectiveness of your QMS, while simultaneously enhancing data accuracy and facilitating the tracking of key metrics for your organization.

We welcome the opportunity to discuss your specific compliance needs and explore how our team can help you achieve your goals. Feel free to reach out to us at any time to learn more about our services and how we can support your business.