Excellence in Medical Device QMS Implementation and Auditing
MD Compliance is your trusted partner in ensuring compliance and maintaining the effectiveness of your Quality Management System (QMS). We specialise in QMS implementation and auditing, helping your organisation achieve the highest standards in product quality and regulatory compliance.
Our Services
QMS Implementation
Implementing an effective Quality Management System is crucial for medical device companies. We have a full range of document templates that will be tailored to your organisation and your specific needs. Our expert consultants will guide you through the entire process, ensuring your QMS aligns with ISO 13845, FDA QMSR (if applicable) and meets all applicable industry standards and regulations, including all required documented processes and template forms for Design and Development, Verification and Validation Testing, Risk Management, Usability Engineering, Customer Complaint Handling, Adverse Event Reporting and Field Safety Corrective Action (FSCA).
Here's How It Works - The Journey of a QMS Implementation
Key Starting Points
1
- Management commitment to regulatory compliance
- Understanding of the requirements
- Plan to ensure actionable and realistic outcomes
Key Pains/Constraints
2
- Team members are sceptical
- Limited time / Competing priorities
- Tools do not exist
Context
3
- We'll gain an understanding of your company, your product(s), your values and your existing working practices, not forgetting your suppliers and your customers.
- Once we understand what makes you tick as an organisation, we’ll be able to quickly and efficiently customise and tailor the documentation so that it works for you!
Key Activities and Tasks
4
- Combination of remote and onsite working to ensure that everyone understands the outcomes
- Document and share results
- Go Live!
- Prepare for third-party certification
- Training and support
Introducing new practices and processes to your organisation can seem daunting (having implemented dozens of quality management systems over the years, we really do understand!) but it's also an exciting opportunity to refine and reinforce your 'Culture of Quality'. You want to inspire others to co-create and innovate together, but at the same time everyone must be on the same page when it comes to meeting regulatory requirements.
Once your QMS is up and running, we’ll continue to work with you and your team to ensure full compliance of your new QMS by tailoring the document set to suit your way of working and "holding your hand" while you get comfortable with the new processes and how to manage the documentation.
Already have ISO 9001 certification? No problem! We have experience upgrading or supplementing your existing ISO 9001 QMS to ensure that it meets the requirements of ISO 13485.
QMS Auditing
Regular internal audits are essential to maintaining a robust QMS. Our experienced auditors conduct thorough, independent assessments of your entire QMS, or specific areas you’ve identified, and will highlight any gaps and areas for improvement and ensure ongoing compliance with regulatory requirements. We provide detailed reports and actionable recommendations that will add value to your QMS processes. Our audits are routinely leveraged by many of our customers to fulfil their Internal Audit process requirements each year, and audits (and gap assessments) can also serve as “effectiveness checks” for your open CAPAs. We also perform mock audits to help ensure your readiness for the all-important external audits/inspections!
Our Expertise
Regulatory Audit Preparation
Master the art of preparing for regulatory audits, ensuring your organisation is compliant with the latest standards and regulations.
Inspection Readiness Training
Navigate inspections seamlessly with our comprehensive training programs that cover all aspects of the inspection process.
Mock Audits and Inspections
Simulate real-world scenarios with our mock audits and inspections to identify areas for improvement and boost preparedness.
Customised Training Solutions
Tailor our training programs to address the specific needs and challenges of your organisation, ensuring a personalised approach to audit readiness for many of the key global markets, including MDSAP audits.
Post-Audit Remediation
If you’ve just experienced an audit or inspection that didn’t go as well as you hoped, please contact us for advice on remediation. We have years of experience helping customers understand why Non Conformances (or the dreaded ‘483s’) were issued and can guide you toward successful closure.
Why Partner with MD Compliance?
- Industry Expertise: Our team comprises seasoned professionals with in-depth knowledge of the medical device industry and supplier management.
- Customized Solutions: We understand the unique challenges in your supply chain. Our services are tailored to address your specific needs and requirements.
- Data-Driven Insights: Leverage actionable insights from our audits to make informed decisions, optimise your supply chain, and drive continuous improvement.
- Reliability and Trust: Count on us for transparent, reliable, and thorough auditing services that build trust with your stakeholders.
Supplier Auditing
Elevating Quality through Comprehensive Medical Device Supplier Auditing
MD Compliance is your trusted partner in ensuring control over those critical suppliers you rely on for the materials, components and services needed to keep your medical devices safe and effective. See details below.
Our Supplier Auditing Services
Comprehensive Supplier Assessments
We conduct thorough assessments of your medical device suppliers, evaluating their processes, quality controls, and adherence to regulatory requirements. Our audits cover a spectrum of critical areas to ensure the reliability and safety of your supply chain.
Risk Mitigation Strategies
Identifying and mitigating risks in your supply chain is paramount. Our expert auditors work closely with you to develop effective risk management strategies, safeguarding your operations against potential disruptions and ensuring a seamless flow of high-quality materials.
Regulatory Compliance Assurance
Stay ahead of regulatory changes and ensure that your suppliers align with the latest industry standards. Our auditing services are designed to confirm and maintain compliance with global regulatory requirements, giving you confidence in the quality of your sourced components.
Take the First Step Towards Supplier Excellence
Get Started Today
Ensure the quality and compliance of your medical devices. Contact us today to discuss how MD Compliance can support your QMS implementation and auditing needs.
