Quality Assurance Services
Quality Management Systems (QMS)
Development, implementation, and maintenance of QMS compliant with standards.
Training & Education
Provision of training programs for regulatory affairs, quality management, and other areas.
ISO13485:2016 Compliance
If you are looking for a reliable and professional ISO13485 consultancy service for medical devices, you have come to the right place.
We have a team of experienced and qualified consultants who can help you with every aspect of ISO13485 certification, from gap analysis to documentation, training, auditing and post-certification support. We can help you achieve compliance with the international standard for quality management systems for medical devices, and ensure that your products meet the highest safety and performance requirements.
Whether you are a manufacturer, distributor, importer or exporter of medical devices, we can tailor our services to suit your specific needs and budget. Contact us today to find out how we can help you with ISO13485 consultancy service for medical devices.
MDSAP Compliance
MDSAP stands for Medical Device Single Audit Program.
It is a global initiative that allows medical device manufacturers to undergo a single audit to demonstrate compliance with multiple regulatory requirements. We help you prepare for the audit, identify and address any gaps in your quality management system, and achieve certification in a timely and cost-effective manner.
We can also help you maintain your certification and keep up with the changing regulatory landscape.
Auditing
If you are a manufacturer or distributor of medical devices, you need to comply with the regulatory standards and requirements of your target markets.
This can be a complex and challenging task, especially if you operate in multiple regions or countries. That’s why you need an auditing consultancy service that can help you navigate the regulatory landscape and ensure the quality and safety of your products.
QREG can provide you with the following benefits:
- Expert guidance and support from qualified and experienced auditors who understand the specific requirements and expectations of different regulators and customers.
- Comprehensive and customized audits that cover all aspects of your medical device lifecycle, from design and development to manufacturing, distribution, and post-market surveillance.
- Objective and independent assessment of your compliance status and identification of any gaps or risks that need to be addressed.
- Access to global network of accredited certification bodies that can issue certificates or approvals for your products in various markets.
- Continuous improvement and learning opportunities through feedback, recommendations, and best practices.
eQMS Integration
If you are looking for a reliable and professional eQMS integration consultancy service for medical devices, you have come to the right place.
We have the expertise and experience to help you implement and maintain an effective and compliant eQMS system that meets the requirements of ISO 13485, FDA 21 CFR Part 820, MDR, and other relevant regulations. Whether you need assistance with gap analysis, process design, validation, training, or auditing, we can provide you with customized solutions that suit your needs and budget.
Contact us today to find out how we can help you achieve your quality goals and improve your business performance.
eQMS Integration
CAPA Management
CAPA management is a specialized service that helps medical device manufacturers and distributors to identify, analyse, and correct any nonconformities or defects in their products or processes.
CAPA stands for Corrective and Preventive Action, and it is a key component of quality management systems and regulatory compliance. CAPA management consultancy service for medical devices can assist clients with developing and implementing effective CAPA plans, conducting root cause analysis, documenting and reporting CAPA activities, and verifying the effectiveness of CAPA actions.
We can also provide training and guidance on best practices and industry standards for CAPA processes.
