Quality Management Systems 

Expert QMS consulting and training services to streamline your operations.

Eleven Borders can help you establish a quality management system (QMS) to meet the needs of your business. As trained notified body, MDSAP, MDR 2017/745 and ISO 13485 lead auditors, we offer an insider’s understanding of how to establish,  maintain and certify your QMS to meet global regulatory requirements.

Our knowledge and experience are based on hundreds of external, internal, and supplier audits, as well as firsthand experience planning and implementing systems for certification to 13485/MDR/Australian Regulations and compliance with the US Quality System Regulations (21 CFR 820). We can also help establish your QMS to comply with the Medical Device Single Audit Program (MDSAP).

We offer a range of QMS services, including:

• General QMS consulting
• QMS training and learning management systems
• QMS gap assessments according to ISO 13485, 21 CFR 820, MDR & the Australian Regulations.
• Implementation and maintenance of the QMS.
• Implementation, design and validation of various QMS software platforms
• Developing QMS manuals, policies, SOPs, work instructions, forms and templates.
• ISO14971 risk management
• External audit preparation and management
• Internal audits
• Supplier audits