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PRP COMPLIANCE CASE STUDY
Fast-Track 510(k) Clearance for an AI-Enabled Wearable Medical Device Problem
Problem
An early-stage medical device company faced significant challenges in obtaining FDA 510(k) clearance for their AI-embedded wearable digital medical device. The device incorporated Software as a Medical Device (SaMD) functionality and multiple complex electrical components, making the regulatory submission particularly intricate. The company lacked internal regulatory expertise and needed a streamlined approach to ensure a rapid clearance process without compromising compliance.
Solution
PRP Compliance deployed a regulatory expert specializing in AI-driven medical devices, SaMD, and complex electrical components. Our approach included:
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Developing a robust 510(k) strategy tailored to AI-based software and electrical components.
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Performing gap assessments to identify potential deficiencies before submission.
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Drafting and compiling all required documentation, including software validation, cybersecurity, and risk management per FDA and IEC 62304 guidelines.
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Engaging in pre-submission discussions with the FDA to ensure alignment on regulatory expectations.
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Managing real-time FDA feedback to expedite approval.
PRP Compliance’s deep expertise in AI-driven SaMD and complex medical device regulations enabled a fast and seamless 510(k) approval, allowing our client to focus on innovation and commercialization. We achieved 510(k) clearance in just 90 days—well ahead of industry norms—while successfully addressing complex AI-based software validation and hardware integration challenges. As a result, the company was able to launch their innovative wearable medical device on schedule, securing an early market advantage.
PRP COMPLIANCE CASE STUDY
Streamlined Integration Secures ISO & MDSAP
Problem
A large Medical Device manufacturer had upcoming ISO 13485:2016 and MDSAP audits. They had recently acquired another company and had to integrate the new company's quality system and address several gaps.
Solution
PRP Compliance deployed an ISO 13485:2016 and quality system integration Subject Matter Expert and support resources to assist with both integration activities as well as preparation for ISO 13485:2016 and MDSAP. PRP Compliance's experts were an integral part of the client team. The facility was the first facility at the company to pass MDSAP and achieve ISO 13485:2016 certification. With PRP Compliance's guidance, they were also able to present and defend their integration strategy, and how their procedures interface to support a working, compliant Quality System.
PRP COMPLIANCE CASE STUDY
Labeling Compliance Made Clear
Problem
A mid-sized Medical Device company with hundreds of products required guidance regarding classification of products as cosmetics or Class I medical devices and the related claims made on labeling, packaging, and IFUs. The company had recently received 483 findings related to their Quality System and wanted to be proactive to ensure proper alignment of their labels with FDA regulations.
Solution
PRP Compliance assigned one of our Labeling Subject Matter Experts to review the client's products, determine the appropriate classification, and provide guidance on the necessary labeling elements for appropriate compliance. The client then took this knowledge and was able to have their marketing team update all labels, packaging, and IFUs appropriately.
PRP COMPLIANCE CASE STUDY
Achieving EU MDR Compliance
Problem
A mid-sized Medical Device Manufacturer with hundreds of CE Marked products needed support with their EU MDR efforts. They had not yet identified their gaps and their Regulatory leaders did not have experience with EU MDR and the aspects necessary to comply. They had a scheduled audit with their notified body and needed to ensure compliance to maintain the CE Mark and ability to continue selling products in the EU.
Solution
PRP Compliance deployed an EU MDR Subject Matter Expert as well as support resources to assist with both the gap assessment and compliance execution efforts. PRP Compliance utilized our EU MDR Gap Assessment template to review the client's current technical files, CERs, Post-Market Surveillance processes, packaging and labeling, etc. to identify gaps. PRP Compliance then worked with the client team to remediate the gaps to achieve compliance with the new regulation.
PRP COMPLIANCE CASE STUDY
Regulatory Expertise Secures 510(k) Clearance
Problem
A large medical device company required assistance with developing and updating multiple 510(k) documents.
Solution
PRP Compliance assigned a 510(k) expert with specific therapeutic expertise to complete these efforts. The company received approval on their new 510(k)s and completed the revisions to their 510(k)s to comply with FDA regulations.
PRP COMPLIANCE CASE STUDY
Strategic Pathway to De Novo Approval
Problem
An early stage Class II medical device company required guidance on regulatory pathways to bring products to market in the US.
Solution
PRP Compliance deployed a Regulatory Strategy expert to advise the client on the most appropriate and strategic regulatory pathways. Our expert determined the appropriate device classification and evaluated the FDA anticipated response to a desired Breakthrough Designation or De Novo pathway. Our expert then authored the De Novo application which was later approved by the FDA.
PRP COMPLIANCE CASE STUDY
Risk-Based Audit Plan Enhances Supplier Compliance
Problem
A mid-size company required support with developing a risk-based quality audit plan and then executing on the plan. The company had many suppliers and wanted to implement a plan that ensured compliance with both FDA and EU MDR guidelines for supplier quality.
Solution
PRP Compliance deployed a Risk Assessment SME to assist the team in developing a risk-based quality audit plan. PRP Compliance then deployed a team of Certified Quality Auditors to perform the necessary quality audits. PRP Compliance's auditors provided not only audit reports but also took a collaborative approach that led to identifying areas of suggested process and quality improvement.
PRP COMPLIANCE CASE STUDY
PRP Compliance Prepares Client for GUDID & EUDAMED Success
Problem
A mid-sized Medical Device Manufacturer of Class I devices required assistance in prepping for GUDID and EUDAMED.
Solution
PRP Compliance assigned our UDI Subject Matter Experts and support resources to assist with creating a syndication hub to submit product and device data securely. Our experts assisted with identifying the necessary UDI data elements and aggregating the internal product master data from multiple sources into a single repository. PRP Compliance's team also validated the data prior to submission. With PRP Compliance's assistance, the client completed their GUDID project effectively and is well prepared for EUDAMED.
PRP COMPLIANCE CASE STUDY
Full-Scope Support Secures EU MDR Compliance
Problem
A mid-sized medical device company required regulatory strategy guidance as well as execution resources to comply with EU MDR.
Solution
PRP Compliance assigned one of our Regulatory Strategy EU MDR experts to provide project strategy guidance as well as project management. We also assigned a team of technical writers and literature search experts to execute updating multiple technical files and CERs. The client's notified body reviews were successful and they received certification.
PRP COMPLIANCE CASE STUDY
From Warning Letter to Production Restart
Problem
A major Medical Device manufacturer received an FDA Warning Letter for multiple reasons including failure to validate a manufacturing process that could not be fully verified by subsequent inspection and testing, to ensure the process met specifications, failing to analyze quality data to identify existing and potential causes of nonconforming product, and failure to validate the corrective action to ensure the action is effective and does not adversely affect finished product.
Solution
PRP Compliance deployed an onsite team of 15 Quality professionals to investigate the root causes of nonconformance, develop and implement Corrective and Preventive Actions (CAPAs), perform process validation, and internal audits to enable our client to successfully resume production. PRP Compliance also provided Subject Matter Expertise and support in FDA remediation, supplier auditing, labeling, data analytics, and technical documentation.
PRP COMPLIANCE CASE STUDY
ISO 13485:2016 Gap Assessment
Problem
A global manufacturer with Class I Medical Devices was challenged with both subject matter expertise and resources to address ISO 13485:2016.
Solution
PRP Compliance provided an ISO 13485:2016 SME to perform a Gap Assessment. Our SME prepared a detailed report on gaps identified and then supported the client in updating their Quality Manual and implementing and documenting changes to comply with ISO 13485:2016 guidelines.
PRP COMPLIANCE CASE STUDY
Post-Market Surveillance Strategy for Global Compliance
Problem
A global medical device manufacturer required assistance with Post-Market Surveillance guidance.
Solution
PRP Compliance assigned a Post-Market Surveillance SME with expertise in the particular therapeutic area. The consultant provided guidance on Post Market Clinical Follow-Up and the necessary surveillance to comply with US and EU regulations.