Team Elexes 
Elexes Team 
Wearables Regulatory and Quality Consultancy Services
With the years of experience we hold in the medical device regulatory and quality experience, we offer support to all the companies developing wearable devices.
Right from helping you meet regulatory requirements, design, and development compliance to post-market surveillance, we can assist you with it all.
What Are Wearable Devices?
Wearable devices refer to technology worn on the body that collects or monitors data. These devices can range from simple wellness trackers to complex medical-grade devices, such as heart rate monitors, glucose monitors, or fitness trackers. As they often incorporate advanced features like wireless communication, software integration, and user interfaces, they face both general and specific regulatory hurdles. Ensuring safety, efficacy, and data privacy is key to getting these devices to market and maintaining compliance throughout their lifecycle.
Key Regulatory and Quality Document Requirements for
Wearables We Can Help You With
We offer expertise in helping you go through the regulatory pathway established for wearable devices.
Software Development Documentation
Our team ensures your wearable’s software meets critical regulatory standards, including software requirement specifications, validation protocols, cybersecurity measures, and lifecycle processes. We follow IEC 62304 standards to ensure the software is robust, secure, and compliant.
Human Factors and Usability Engineering
Ensuring usability and minimizing user errors are essential for wearables, especially for medical-grade devices. We conduct usability testing and human factors engineering to ensure your device is intuitive and compliant with FDA and MDR guidance.
Risk Management File
We provide thorough risk assessments and ensure that all potential risks are identified, mitigated, and documented as part of your risk management file.
Clinical Validation Data (if applicable)
Our experts ensure your labeling and Instructions for Use (IFU) are clear, concise, and compliant with both general consumer and medical device regulations. We simplify user understanding while adhering to regulatory requirements for a wide range of audiences.
Wireless Communication and EMC Testing
Wearables often rely on wireless communication for connectivity. We help ensure compliance with the FCC, ETSI, and IEC 60601-1-2 standards, ensuring your device operates safely and effectively in its intended environment.
Data Integrity and Privacy Reports
We assist in managing the risks related to data privacy, ensuring compliance with regulations like GDPR (EU) and HIPAA (US). Our team works to safeguard the user data processed by wearable devices and ensures compliance with all privacy laws.
Design Validation and Verification Reports
We help verify that your wearable meets both design specifications and user needs. These reports confirm that your device performs as expected and complies with regulatory standards, supporting your CE marking or FDA submission.
Post-Market Surveillance Plan
We assist with developing a post-market surveillance (PMS) plan that focuses on software updates, bug fixes, and vigilance reporting. Our team ensures that your wearable continues to meet safety and performance standards after reaching the market.
Post-Market Documents for Wearables
Our job doesn’t end with getting your products on the market. We continuously monitor your device’s performance and help you maintain regulatory compliance.
Our Post market document support services include the following:
⦿ PMS Plan
⦿ Cybersecurity Monitoring Reports
⦿ Data Privacy Compliance Reports
⦿ Software Version Control Documentation
⦿ Adverse Event Report
⦿ User Feedback and Complaint Logs
⦿ Performance Monitoring Reports
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
Then 256+ Global
Clients
We’re Best Insurance Company
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?
Latest News & Blog
Read Our Latest Articles
