Wireless performance, security and privacy solutions for medical devices
EMC Testing for Wireless Technology Contained in Medical Devices
Many portable medical devices incorporate wireless technology which may present risks for life-supporting equipment and other applications. To ensure compliance and prevent interference, you must validate your device to electromagnetic compatibility (EMC) standards. Intertek has the facilities and expertise to help you identify and understand the regulatory requirements applicable to your device, while managing your overall testing to these standards and more:
- FCC Part 15
- FCC Part 18
- Industry Canada: ICES-001
- Industry Canada: Radio Standards Specifications (RSS)
Software Applications and Devices
Software testing and testing of applications and content for mobile devices and networks can becumbersome, due to global requirements, continuously evolving testing standards and the growing number of handsets and devices. We offer testing scalability and a set of flexible andmobile-oriented Quality Assurance (QA) services designed to shorten your product’s time to market.
- Device compatibility testing
- Customized testing strategies
- QA and management tools
- The industry’s largest handset inventory
- Access to all major mobile platforms
- Advisory Expertise
Unlock the full potential of your medical device by mastering wireless coexistence and discover how FDA requirements for wireless testing can impact your device’s performance and regulatory success.
Our 6-Point Security Check
With Intertek's expertise and experience in developing and guiding software and device security, you will be provided the information you need and the confidence you deserve when developing new software and devices. Our 6-Point Check consists of:
1. Scan according to OWASP Recommendations
We use custom and off-the-shelf automated tools that scan web applications to look for known security vulnerabilities such as cross-site scripting, SQL injection, command execution, directory transversal, and insecure server configuration.
2. Review Web Services configuration
We will review and identify the operations of your web service and provide feedback on any vulnerabilities or misconfigurations we find using automated and manual test methods.
3. Review Data Security Logs
During our testing we will work with your team to review and evaluate security logs generated during our tests and provide actionable information on any identified security gaps.
4. Discover potential SQL Injection points
We will identify how your web application works with your database and construct a series of automated and manual simulated scenarios to help identify any potential exploit paths.
5. Validate Security Controls
We will review and verify current security protocols and provide feedback on the current implementation and provide guidance for updated security measures if needed.
6. Recommend remediation steps
Following our tests, we will provide up to three hours of consultation to discuss and train on our findings and potential remediation techniques.
Knowledge Center
Evolution of the Home Healthcare Market and Medical Device Compliance
White Paper | Webinar Recording
Ventilator Production: Introductory Guide to Regulatory Requirements
Critical Care Medical Devices: First-In-Queue Priority
Product Listing & Marking Strategies White Paper
IEC 60601-1-2 Edition 4 White Paper
Updated FCC Approval Process Webinar
Extractables and Leachables Studies Fact Sheet
Five Steps to Medical Device Commercialization in the United States White Paper
Making Green Profitable: Using IEC 60601-1-9 as a Competitive Advantage White Paper
Related Links
- ETL Mark The Industry's Fastest Certification Program
- Search and Buy Medical Device Standards
- Reese's Law – ANSI/UL 4200A-2023
- My Test Central
- Directories
- Certification Marks
- Global Research & Certification
- Medical Podcast - Compliance with Clarissa
- Satellite Data Acceptance Program
- Planning for Quality through Disruptions
- Intertek's world-class team of Medical Experts
- Intertek Protek - The world’s first industry-agnostic, end-to-end health, safety and wellbeing assurance program
*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.