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 we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates®, we offer a wide variety of services for medical device 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 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 to your notified body.
Cybersecurity Medical Device Services
- Supporting cybersecurity aspects of design control using secure design principles for the entire Product Lifecycle.
- Performing Gap analyses on your device’s current cyber resilience.
- Utilizing threat risk modeling to identify potential vulnerabilities or the absence of appropriate safeguards for future threats.
- Generation of regulatory submission documentation per the FDA’s cybersecurity guidance, as well as the EUMDR MDCG 2019-16 cybersecurity guidance.
- Perform a cyber risk analysis to manage confidentiality, integrity, and availability and reduce attack surface area.
- Create a software bill of material for purchased components of the product to better manage vulnerabilities.
- Independent 3rd party validation of cybersecurity requirements.
- Analysis and evaluation of current ISO 14971 risk management procedures.
Trustworthy Medical Device Cybersecurity
- Contains hardware, software, and/or programmable logic that is based on FDA cybersecurity guidance and regulatory standards.
- Provides a reasonable level of availability, reliability, and correct operation.
- Is reasonably suited to performing its intended functions.
- Adheres to generally accepted security procedures.
Cybersecurity Medical Device Best Practices
- Identify assets, threats, and vulnerabilities.
- Assess the impact of threats and vulnerabilities on the device’s safety and performance.
- Assess the likelihood of a threat as well as the likelihood of a vulnerability being exploited.
- Determine security risk levels and suitable mitigation strategies.
- Evaluate residual security risk and risk acceptance criteria.
Medical Device Cybersecurity Consulting
When you’re looking for a medical device consulting firm for your cybersecurity, or want to better understand the relationship between healthcare and cybersecurity, you need a partner with industry knowledge who can customize a compliant solution. With a unique blend of industry experts and FDA veterans, the team at Regulatory Compliance Associates® Inc. is here to help.
Since 2000, we’ve worked with thousands of medical device companies around the world to accelerate regulatory, compliance, and quality throughout the entire product life cycle. Whether you’re a small medical instruments startup or a multinational oxygen saturation monitor corporation, we take your individual needs into account.
Software as a medical device can help patients self-manage their care without providing specific treatment or treatment suggestions. RCA’s design controls and DevOps team can help you save time for healthcare providers by automating repetitive tasks or common work. Our global network of experts can provide your team with engineering consulting in software design, development, cybersecurity, test systems, and manufacturing systems. That helps keep your team and medical devices in compliance with IEC 62304 and current FDA guidance.
- Investigational Software Guidance
- Device Exemptions
- Development Analysis & Support
- Mobile Platform
- Mobile Application
- Display screens
- Mobile Medical Application
- Accessories to a regulated medical device
- Patient-specific analysis
- Patient-specific diagnosis
- Mobile platforms transformed into a regulated medical device
- 21 CFR 803 Medical Device Reporting
- 21 CFR 806 Corrections and Removals
- 21 CFR 807 Premarket Notification
- 21 CFR 820 Quality System
- Accessories to a regulated medical device
- Device classification
- Class I
- General controls
- Class II
- Special controls in addition to general controls
- Class III
- Premarket approval
- Class I
- Medical Device Studies
- Intended Use
- Significant Risk (SR)
- Non-significant Risk (NSR)
- Intended Use
About RCA’s Medical Device Consulting Services
The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates® medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.
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. Regulatory Compliance Associates® 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.
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 Regulatory Compliance Associates® medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.
At Regulatory Compliance Associates®, 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, Regulatory Compliance Associates® 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 is Regulatory Compliance Associates® 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 Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® 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
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® 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 Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.
- Gap Assessments
- Internal Audits
- Employee Training
- Notified Body Response
Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® 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 Regulatory Compliance Associates®, 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, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.
- 21 CFR 210
- 21 CFR 211
- Outsourced Staffing
- Facility Validation
- Equipment Validation
Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for remediation support. Regulatory Compliance Associates® 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 Regulatory Compliance Associates® a competitive differentiator in the remediation space.
- Quality System
- Technical File
- Design History File
- Data Integrity
Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® 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 Regulatory Compliance Associates
Regulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:
- Life Sciences
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
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 5,000+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.
Commitment to Quality
Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.
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