Comprehensive Auditing Services for Medical Device Companies
Ensure compliance, quality, and efficiency with our expert audits.
Don’t settle for standard audits—demand insights that drive your business forward. Fission Consulting’s expert auditors bring clarity and confidence to your compliance journey.
Outsource Your Medical Device Audits to the Experts
Audits are essential for maintaining compliance and ensuring the quality of your medical devices. Regular audits help identify areas for improvement, mitigate risks, and ensure adherence to regulatory standards.
Outsourcing your audits to experts offers numerous benefits. Our team brings a wealth of experience and specialized knowledge, ensuring thorough and objective assessments. We work with organizations of all sizes in the medical device industry, from startups to large enterprises.
We don’t just audit, we add value to your Quality Management System (QMS) and operations. Our audits focus on systemic, high-risk issues that could lead to FDA citations or warning letters. We look beyond compliance, promoting best practices that drive business excellence.
We also provide post-audit support, guiding you through the remediation process and assisting with closing audit findings. Our goal is to ensure your company not only meets regulatory requirements but excels in quality and efficiency.
Benefits of Outsourcing Audits:
- Access to specialized expertise
- Objective and unbiased assessments
- Cost-effective and efficient
- Reduced internal workload
- Enhanced compliance and quality control
Our Auditing Services
We offer a range of auditing services tailored to meet the unique needs of the medical device industry. Whether you’re a software company, a manufacturer, or rely on multiple suppliers, we have the expertise and solutions to ensure your compliance and quality standards are met.
Remote Desktop Audits
Our remote desktop audits are conducted entirely offsite using virtual tools and platforms. Ideal for software and virtual manufacturers.
starting at
$1,500
- Cost Effective
- Minimal disruption to operations
- Quick turnaround times
Hybrid Audits
Hybrid audits combine remote desktop preparation with onsite inspections. Ideal for firms with manufacturing activities.
starting at
$5,000
- Thorough and comprehensive
- Best value for manufacturers
- Detailed and accurate
Supplier Audits
Supplier audits evaluate and ensure that your suppliers meet quality standards and regulatory requirements.
starting at
$3,000
- Protect your supply chain
- Ensure supplier compliance
- Maintain high quality standards
Custom Quotes
For enterprises and multi-location audits, we offer custom quotes to meet your specific needs. Contact us to discuss your requirements and get a tailored solution.
Remote Audits
Conducted entirely offsite, leveraging virtual tools and platforms. This approach is cost-effective, minimizes disruption, and offers a quick turnaround.
- Benefits: Save on travel and accommodation costs, minimal disruption to operations, quick turnaround times.
- Ideal For: Software companies, virtual manufacturers, and any organization looking for a cost-effective and efficient audit solution.
Hybrid Audits
Hybrid audits combine remote desktop preparation with onsite inspections. This thorough and comprehensive approach provides the best value for companies with physical manufacturing processes.
- Benefits: Combines the benefits of remote and onsite audits for a detailed assessment, best value for manufacturing firms, detailed and accurate assessments.
- Ideal For: Companies with complex manufacturing processes and those needing an in-depth audit approach.
Supplier Audits
Supplier audits are designed to evaluate and ensure that your suppliers meet quality standards and regulatory requirements. This can be conducted onsite or fully remote, depending on your needs.
- Benefits: Protect your supply chain, ensure supplier compliance, maintain high quality standards.
- Ideal For: Companies relying heavily on external suppliers, needing ad-hoc supplier auditing, or seeking a comprehensive supplier auditing program.
Custom Quotes
For projects that deviate from these packages or require a unique approach, we offer custom quotes to meet your specific needs. Contact us to discuss your requirements and get a tailored solution that fits your business perfectly.
Why Choose Fission Consulting?
Choosing the right partner for your medical device audits is crucial. At Fission Consulting, we don’t just check boxes—we deliver audits that add genuine value to your business. With a focus on practical outcomes and long-term improvement, our approach ensures you’re not just meeting regulatory requirements but also enhancing your overall operations.
Our deep industry expertise, combined with a commitment to post-audit support, makes us the trusted choice for companies serious about compliance and quality.
Value-Added Auditing
Our audits go beyond compliance, enhancing your QMS and operations. We use best practices that deliver real business value.
Risk-Based Approach
We focus on systemic, high-risk issues that matter most to your business, avoiding unnecessary nitpicking and fluff.
Post-Audit Support
We are available to provide hands-on guidance through remediation, ensuring you can close out audit findings effectively.
Expertise and Experience
Our team brings deep expertise from both startups and Fortune 500 companies, delivering practical, impactful insights.
Comprehensive Services
Beyond audits, we offer a full suite of services, including regulatory compliance, engineering, and project management.
Specialized Knowledge
We focus solely on medical devices, ensuring a thorough and nuanced understanding of industry challenges. We know med devices.
OUR APPROACH
Our Medical Device Audit Process
1. Initial Consultation
understanding your needs
The first step involves a detailed consultation to understand your specific needs, challenges, and objectives.
We delve into the specifics of your business, focusing on your operational nuances and compliance challenges. Our team listens carefully to ensure we grasp the full scope of your needs, setting the foundation for a truly customized audit process.
With this deep understanding, we craft an audit strategy that aligns perfectly with your goals. This personalized approach ensures that every aspect of your audit is relevant and beneficial, delivering insights that drive real improvements.
2. Audit Planning
customizing the audit plan
We develop a tailored audit plan that aligns with your specific needs and regulatory requirements.
Our team meticulously maps out the audit process, ensuring that every detail is considered. We focus on the critical areas that impact your compliance and business objectives, providing you with a comprehensive audit strategy.
This customized plan not only meets regulatory standards but also addresses your unique operational needs. By aligning the audit with your specific goals, we ensure that the process is both thorough and efficient, minimizing disruptions while maximizing value.
3. Execution
conducting the audit
We conduct the audit with precision, whether remote, hybrid, or onsite.
Our auditors implement the plan with meticulous attention to detail, using a risk-based approach to identify and address the most critical areas. Whether onsite or remote, we ensure the audit is conducted efficiently and effectively.
Throughout the process, our focus remains on uncovering opportunities for improvement and ensuring compliance. This thorough execution lays the groundwork for actionable insights and meaningful enhancements in your operations.
4. Reporting & Recommendations
delivering actionable insights
We provide clear, actionable reports with insights that go beyond compliance.
After the audit, we compile detailed reports that outline our findings in a clear and concise manner. We don’t just identify issues; we also provide practical recommendations to address them, helping you enhance your operations and compliance.
These insights are designed to add value, guiding you towards improvements that benefit your business. Our goal is to ensure you not only meet regulatory requirements but also drive continuous improvement in your processes.
5. Follow-Up Support
guiding you through improvements
We offer ongoing support to help you implement audit findings and maintain compliance
Our relationship doesn’t end with the audit report. We offer follow-up support to help you implement the recommended changes and address any compliance issues. We’re here to guide you through the remediation process, ensuring you achieve your objectives.
This ongoing partnership means you have access to expert advice whenever you need it. We help you stay on track, maintaining compliance and continually improving your operations for long-term success.
FAQ
We know you likely have some unmet questions, so we’ve tried to address most of those here, but would be glad to hear from you if you have additional questions you would like to have answered.
What is included in a medical device audit?
Our medical device audits include a comprehensive review of your quality management system, processes, and compliance with relevant standards and regulations. We assess documentation, conduct interviews, and perform inspections to ensure thorough evaluation.
How much do audits cost?
Our audit pricing varies based on the type and scope of the audit. Remote Desktop Audits start at $1,500, Hybrid Audits start at $5,000, and Supplier Audits start at $3,000 for onsite. For customized projects, we offer personalized quotes.
What are the benefits of outsourcing audits?
Outsourcing audits to experts like Fission Consulting provides several benefits: access to experienced auditors, unbiased assessment, cost-effectiveness, and reduced disruption to your operations. We also offer post-audit support to help you implement recommendations.
What is the difference between remote, hybrid, and supplier audits?
Remote Desktop Audits are conducted entirely offsite using virtual tools, ideal for software and virtual manufacturers. Hybrid Audits combine remote preparation with onsite inspection, suitable for firms with manufacturing activities. Supplier Audits ensure your suppliers meet quality standards, either onsite or remotely.
How long does an audit take?
The duration of an audit depends on its scope and complexity. Remote Desktop Audits typically take 1-2 days, Hybrid Audits last 2-3 days onsite plus preparation time, and Supplier Audits include one day onsite or fully remote assessment.
Do you offer post-audit support?
Yes, we can provide ongoing support after the audit to help you implement our recommendations and close any identified gaps. Our team is committed to ensuring your compliance and continuous improvement.
Can you handle multi-location audits?
Absolutely. We offer custom quotes for enterprises and multi-location audits to address the unique challenges of auditing across multiple sites.
What standards do you audit to?
We audit to various standards, including ISO 9001, ISO 13485, MDSAP, and FDA QSR. Our team ensures your compliance with all relevant regulatory requirements.
How do I schedule an audit?
Scheduling an audit is easy. Simply contact us to discuss your needs, and we’ll arrange a time that suits you. We offer flexible scheduling to minimize disruption to your operations.
What if I have more questions about medical device audits?
If you have additional questions, feel free to reach out to us. Our team is here to provide the information and support you need.
At Fission Consulting, we’re not just another consultancy—we’re your dedicated partners in navigating the complexities of the medical device industry. With a team of expert consultants spanning all core service areas, we offer unparalleled expertise and guidance at every stage of your journey, from concept to market dominance.
Audit Request Form
Ready to request a specific audit? Please provide details below.