A quality and regulatory consultancy for SaMDs
Our Services
ISO 13485,IEC 62304, and 21 CFR compliant Quality Management System (QMS) Implementation
We are your quality partner when you need to implement a brand new QMS or improve an existing QMS. Beginning from drafting a Quality Plan to full-fledged QMS Implementation, we do it all for you. If you are interested in implementing an Electronic Quality Management System (eQMS), we have expertise in implementing all the major eQMSes including Confluence. If you already have an existing QMS (typically ISO 9001 compliant) and do not want to re-invent the wheel, we can conduct a gap analysis to determine the documentation required for ISO 13485 or 21 CFR Part 820 compliance.
Internal Audits
Start-ups typically have only one or two Quality team members, making it impossible for them to audit their own work. We work with you to conduct the Internal Audits to fulfil the QMS requirements according to your schedule. We can also conduct Supplier Audits on your behalf and prepare your team members to be successful Internal Auditors. Our auditing services include Internal Audits, Supplier Audits, 3rd Party prep Audits, and MDSAP prep Audits.
Regulatory Strategies
Is it a Class II device in the EU? Is it a Class C Software per IEC 62304? What standards are applicable to your device? Should you prioritise an FDA Submission over CE Mark? To prevent starting from scratch later in the Development lifecycle, you must have the answers to all of these questions before starting your actual Product Development journey. We create a Regulatory Strategy to assist you in responding to all of these queries.
Customized IEC 62304 implementation
Customized Software Development Life Cycle process to suit the Software Development methodology utilized by your company. Legacy Software? No problem! We can do gap analysis and determine additional documentation required to be compliant to IEC 62304.