Compliance Assurance & FDA Inspection
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Background
The medical device company received an FDA warning letter and sought Regulatory Compliance Associate® Inc.’s guidance for compliance assurance and remediation strategy. While researching the company’s situation, RCA noticed staff were inexperienced with FDA inspections and could benefit from Inspection Readiness Training.
“RCA not only remediated our warning letter, but they also improved our workforce efficiency and preparedness for agency audits. We didn’t realize what it took to be prepared for an inspection. Prior to RCA, we had cursory reviews by auditors and inspectors, but we always suspected there were issues that weren’t identified. We experienced a thorough inspection when RCA came. Our systems were closely examined by RCA’s mock inspectors, to the point where we really felt like we had been through a real inspection. They identified many deficiencies and areas for process improvement. We now know we are in good shape and are getting better by practicing what we learned. RCA provided great value to us.”
Solution
RCA prepared a response to the FDA and began Inspection Readiness Training throughout the organization. Besides conducting mock inspections, RCA led the company through a compliance assurance process. For example, a planned FDA tour and behavioral training for the staff was conducted. Document review processes, roles and responsibilities were reviewed for both an Inspection Room and Control Room.
Additionally, the compliance assurance process formalized internal procedures and helped prepare staff in answering audit questions. Most importantly, it prepared the internal client team to access documents and provide information to common FDA inspection requests.
Result
The company passed their next FDA inspection with only one minor observation which was easily remediated. The company continued to practice their learnings and will be ready for an inspection, with little or no notice from a regulatory agency.
About RCA’s Medical Device Consulting Services
Our team of over 500 medical device consultant Experts — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. Very few medical device consulting companies have the same expertise in a variety of medical fields.
Cybersecurity
For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if RCA’s medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates Inc.®, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks.
With a well-planned design, along with full visibility of product development and the supply chain, RCA’s medical device consultant Experts can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission services involved with medical technology consulting.
Regulatory Affairs
Regulatory affairs is Regulatory Compliance Associates®‘s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our medical device regulatory consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.
As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent RCA as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. RCA’s medical device consulting company has expertise in both the approval process and post-approval support.
- New Product Approval
- Post-Approval Support
- Outsourced Staffing
- EU MDR
Compliance Assurance
Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.
Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows RCA to handle both simple and complex regulatory compliance challenges within medical device consulting companies.
- Gap Assessments
- Internal Audits
- Employee Training
- Notified Body Response
Quality Assurance
Regulatory Compliance Associates® Inc.’s Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each RCA medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.
In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA, we offer you the medical device consultant assistance you need to monitor these processes and ensure quality compliance every step of the way.
With more than 20 years experience working with medical device consulting companies, RCA’s trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.
- ISO13485
- 21 CFR 210
- 21 CFR 211
- Outsourced Staffing
- MDSAP
- Facility Validation
- Equipment Validation
Remediation Support
Regulatory Compliance Associates® Inc. is widely recognized within medical device consulting companies & the life science industry for remediation support. RCA’s ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.
Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with RCA® a competitive differentiator in the remediation space.
- Quality System
- Technical File
- Design History File
- Data Integrity
- cGMP
Strategic Consulting
Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates®‘s medical device consultancy can help ensure a successful project. RCA’s medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.
Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.
- Manufacturing Optimization
- Product Lifecycle Management
- Mergers & Acquisitions (M&A)
- Due Diligence
- Device Vigilance
- Product Complaints
- Medical Information
About RCA
Regulatory Compliance Associates® (RCA) provides regulatory compliance consulting services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
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