Leave the complexities of managing your Quality Management System (QMS) to us and reduce your compliance costs. Quality Management as a Service enables us to help establish and maintain robust processes, advise on quality best practices and manage critical documentation – all for a fixed monthly fee.
Our proactive approach ensures that your QMS is not just a compliance tool, but a driving force for quality and excellence within your organisation.
Remove the variability of day-rate pricing and maximise the value of our as-a-Service support package with fixed monthly fees and expert support.
We’ll support you every step of the way with both internal and external audits, enabling you to maintain quality and expedite certification.
Leverage our team's experience to support strategic planning, whether this be market expansion or choosing an eQMS, our team are here to support you every step of the way.
We believe compliance should not live in silos. We can review, align and integrate your compliance documentation to make your QMS the foundation of quality management.
Essential to the effective management of a QMS is an experienced Quality and Regulatory professional. Our team has a diverse array of experience managing compliance portfolios for Medical Devices and In-Vitro Diagnostics - leverage their experience to expedite and maintain compliance.
Quality Management as a Service (QMaaS) is designed to support businesses in managing their core quality and regulatory processes in line with ISO 13485. This includes supporting Document Control processes, identifying and addressing Non-Conformities, leading Management Reviews and handling reporting and registration with regulators. QMaaS is your answer to a complete outsourced Regulatory function.
Yes. Our team has a wealth of expertise working in purpose built solutions such as Greenlight Guru, Qualio and SimplerQMS as well as in more bespoke eQMS solutions built in platforms such as Confluence, Jira and Monday.com. We can even advise on transitioning to new solutions if your current solution is not meeting your needs.
Absolutely - we can advise you on planning your development lifecycle and processes, review and help improve your documentation, make sure you’re meeting regulatory requirements throughout your development and maintain your Technical Documentation structure and summary. We can also simplify Risk Management activities by integrating them into your development process and run your Design Reviews to provide final approval of your Medical Device just before release or submission to your Regulator.
Absolutely. Through QMaaS, our expert team is on hand to plan, execute and record internal audits and guide external auditors through your Quality Management System for less stress for you come audit time.
Of course. We don’t believe in developing ‘compliance silos’ and where possible can look to integrate your compliance portfolio within your QMS structure. We can do this with both International Standards such as ISO 27001, ISO 9001 and ISO 42001 as well as with market specific compliance frameworks such as the NHS Digital Technology Assessment Criteria and HIPAA.
Our expert team can handle the entire process of Regulatory approval from conception to product registration. Explore our complete Regulatory services offering below:
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