Team Elexes 
What Are Combination Devices?
Combination devices are products that integrate drugs, devices, or biologics into a single product, making them a unique and complex category of medical products. These devices require extensive documentation to prove safety, efficacy, and compatibility between all components. Depending on the primary mode of action (PMOA)—whether the product functions primarily as a drug, device, or biologic—the regulatory body reviewing the combination device may be the Drug division (e.g., CDER of FDA) or the Device division (e.g., CDRH of FDA).
At Elexes, we guide you through the complexities of combination device development, ensuring all regulatory requirements are met and your product reaches the market efficiently and safely.
How We Help with Key
Design Documents for Combination Devices
We assist you in preparing the critical documentation required for Combination Devices, ensuring compliance and demonstrating the safety and performance of your product:
Primary Mode of Action (PMOA) Analysis
We help identify whether your product functions primarily as a drug, device, or biologic, which determines the regulatory division responsible for its review and approval.
Device-Drug/Biologic Compatibility Testing
Our team supports compatibility testing, including stability studies, interaction testing, and material compatibility assessments to ensure safe and effective integration of the drug and device components.
Clinical Evaluation Report (CER)
We assist in providing evidence of your combination device’s clinical performance and safety, ensuring compliance with regulatory requirements.
Labeling and Packaging Documentation
We assist with developing labeling and packaging documentation that complies with FDA or EU MDR requirements, addressing both the device and drug components.
Design History File (DHF)
We ensure that your design history file complies with 21 CFR 820.30, providing a comprehensive record of the design process for your combination device.
Risk Management File
We help develop a detailed risk management file following ISO 14971, addressing risks arising from the combined use of drugs, biologics, and device components, along with effective mitigation strategies.
Sterilization and Biocompatibility Reports
We help ensure your product meets ISO 11135, ISO 11607, or ISO 10993 standards for sterilization and biocompatibility, demonstrating its safety for patient use.
Post-Market Surveillance Plan
We help develop a comprehensive PMS plan that outlines strategies for monitoring safety and effectiveness of the combination device once it’s on the market.
How We Help with Key Considerations for Combination Devices
We provide support throughout the development process to ensure your combination device meets all regulatory requirements and performs safely:
Clear Identification of PMOA
We help you clearly identify the PMOA of your combination product, which is critical for determining the appropriate regulatory pathway and submission process.
Device-Drug Interaction Studies
Our regulatory experts would conduct detailed interaction studies for evaluation of potential chemical or physical reaction between the drug and device. The goal here is to ensure compatibility and safety.
Design Control Records
We ensure that your design control records include detailed risk analyses per ISO 14971, allowing you to manage and mitigate risks throughout the product lifecycle effectively.
Robust Instructions for Use (IFU)
We support the development of IFUs that provide clear, concise, and comprehensive instructions for handling both the device and drug components, ensuring safe use by healthcare professionals and patients.
How We Help with Post-Market
Requirements for Combination Devices?
After your combination device reaches the market, Elexes helps you stay on top of the necessary post-market documentation and monitoring to ensure continued safety and compliance:
Post-Market Surveillance (PMS) Plan
We assist in developing a PMS plan that outlines methods for collecting real-world safety and effectiveness data on the combination device, ensuring it continues to meet regulatory requirements.
Risk Management Updates
Based on real-world data, we help update your risk management file (ISO 14971), ensuring your device continues to address any emerging risks.
Drug-Device Interaction Reports
We support ongoing monitoring for unexpected chemical or physical reactions between the device and drug components to mitigate any safety concerns.
Stability and Compatibility Reports
We assist in periodic evaluations of the device’s functionality and the drug/biologic’s stability over time, ensuring that both components remain effective throughout the product lifecycle.
Adverse Event and Incident Reports
Our experts make sure that proper documentation is maintained in case of any malfunctions, dosing errors, or side effects caused by the device and are reported to the authority
Labeling Change Documentation
As safety information or usage instructions evolve, we help you update the labeling and packaging to reflect these changes, ensuring ongoing compliance with regulatory requirements.
Periodic Safety Update Reports (PSUR)
As per EU MDR, team at Elexes is well-equiped to ensure safety of your combination device by assisting you to prepare PSURs to summarize the safety trends, risks, as well as vigilance activities.
Our Expertise
Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
Our Services
Our Compliance Assessment Process
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
A Trusted Team of Consultants
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Local Language
Auditor
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Why Choose Elexes?
Expertise
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
Local Regulatory Certification
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
Confidentiality
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Associated Regulatory Authorities.
We’ve More
Than 256+ Global
Clients
The Best RA & QA Consultants
Clients Testimonials
Amazing Feedback Say About Services
Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
“
Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
“
Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
“
Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
“
Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
“
Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
“
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
“
Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
“
Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
“
Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
“
Popular Clients
We’ve 200+ Global Premium Clients
Looking For Regulatory Assistance?
Let's Talk How We Can Help You?
