Welcome to the Remediation Station! We've got live shows with the experts, case studies, and insights to help you get through remediation successfully.
First up, join us Friday, May 8 11:00am ET / 8:00am PT for RQM+ Live #4: Best Practices for Reducing Pain in a Medical Device Remediation Program. Our subject matter experts are talking about remediation programs at medical device companies. DHF and manufacturing remediation resulting from government actions (FDA warning letters, EU's non-compliance reports) are the extreme and we know that the proactive efforts needed for many companies to achieve MDD compliance let alone the jump to MDR are no piece of cake either. Remediation often exhausts the team, brings down morale, and leads to much debate over what is "good enough". Let's talk about best practices to enable remediation efforts to be as pain free as possible. Join us for free by clicking the button below:
Keep reading for more insight on the remediation process and what your company can do to improve your success:
When do medical device companies need remediation?
The need for remediation efforts at a company can be generated for a multitude of reasons. Most often it is the result of an FDA inspection or Notified Body audit that has identified numerous non-compliances. Preferably, internal audits identify areas to focus on proactive remediation efforts to avoid regulatory body findings.
Established device companies typically have known deficiencies that need to be rectified or holes that need to be patched in Design History Files (DHFs), Technical Documentation, Risk Management, or Supplier Controls to name a few.
No matter where you are in the range of having new-to-the-market medical devices or long-established legacy devices, you could find yourself in the situation of needing to remediate.
So, remediation is needed - now what?
The key to successful remediation is to strategically plan your organization’s efforts.
Whether remediation is conducted for proactive or reactive reasons, the tasks to address these regulatory compliance issues can be daunting. To properly achieve an effective resolution, these efforts can require numerous resources and time, potentially disrupting new product development and current operations. Most companies do not have the capacity to plan and execute remediation activities on top of the existing day to day work.
We are seeing firsthand the significant resource drain and impact throughout Regulatory, Quality, and New Product Development functions at many device companies created by remediation efforts on legacy device DHFs to achieve EU Medical Device Regulation (MDR) compliance. Not conducting thorough remediation could lead to delays in your MDR certification or, in some cases, being forced to withdraw your device from the EU market.
The good news is that R&Q has experts ready to go to help you successfully achieve compliance.
How R&Q can help you achieve your goals
Your company may have remediation experience and a strong team, but due to tight response deadlines and capacity constraints, you are struggling to adequately support the remediation effort. On the other hand, you may be going through this type of activity for the first time. R&Q’s expertise can help to drive forward any aspect of your remediation efforts. Our adaptive team can provide:
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- Remediation Project Management - essential planning and oversight of remediation from beginning to end.
- Experienced Resources - our knowledgeable and experienced team members have conducted remediation efforts across many companies and types of medical devices. R&Q can support your efforts on-site or fully remote, freeing up internal resources to continue their much-needed daily operations.
- Subject Matter Experts – don’t have the knowledge to address issues in-house? R&Q has the expertise to guide you. Having outside eyes to review can help to identify some glaring issues and creative solutions that may not be apparent internally.
- Collaboration and Ownership - R&Q has a proven track record of integration into client teams to help effectively drive remediation. This collaboration ensures the effort is not just an outside entity coming in and making changes in your company. R&Q works hand in hand with our clients throughout the process to assure business agreement and ownership.
- Sustainable Robust Resolutions – not just stop the leak and move along …thorough investigation and gap/risk assessments to identify root causes and precise resolutions. The R&Q team will identify the issues and root cause and then work with you to make the appropriate robust changes needed to achieve compliance and avoid reoccurrence.
- Long Term Assurance and Support – R&Q assists in long term compliance assurance by providing periodic Internal Audit services, as well as mock audits conducted by former FDA or Notified Body auditors. R&Q can also provide appropriate training needed for internal client employees regarding compliance, regulatory requirements, and audit preparation.
Regulatory & Quality Solutions (R&Q) provides best practice strategic and tactical solutions to tackle your remediation challenges. Specializing in the United States (US) and European Union (EU) regulatory and quality environments, our team can help your medical device company successfully address deficiencies and remediation efforts related to:
- Notified Body non-conformity reports
- MDD to MDR Compliance
- EU Technical Documentation
- FDA Consent Decrees, 483 Findings, and Warning Letters
- Complaint / Adverse Event and Device Reporting
- Corrective/Preventative Action Plans
- Internal Audit Findings
- Design History Files (DHF)
- Risk Management Programs
- Supplier Quality Control
The R&Q team customizes the level of support needed for your remediation efforts. Whether you need a small audit or a full team to support large scale remediation, R&Q can help every step of the way.
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About Regulatory & Quality Solutions (R&Q):
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQMplus.com.
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