Comprehensive Quality: From Design to Delivery
highest standard of qualtiy
Trust in every dose. Spencer Health Solutions has meticulously crafted and validated spencer, the smart medication dispenser, to meet stringent global regulatory requirements, delivering the reliable performance you demand and the quality you can depend on.
Global Quality Management System
ISO 13485:2016 Certification
Our adherence to ISO 13485:2016 ensures the highest standards in medical device quality management, enhancing product safety and efficacy.
ISO 9001:2015 Certification
We are committed to excellence in quality management, as demonstrated by our ISO 9001:2015 certification, which underscores our dedication to continuous improvement.
ISO 14971:2019 Compliance
Our compliance with ISO 14971:2019 reflects our proactive approach to risk management in medical devices, prioritizing patient safety and product reliability.
Information Security Measures
ISO 27001 Certification
We adhere to the ISO 27001 standard, ensuring a robust information security management system (ISMS) that protects your data with the highest level of security protocols.
Advanced Data Encryption
Our systems utilize AES-256 encryption, a leading standard in data security, to safeguard sensitive information against unauthorized access.
Comprehensive Data Protection
We implement industry best practices to maintain the confidentiality, integrity, and availability of your data at all times.
Product Certifications & Approvals
Safety Certifications
Our products are certified under IEC 60601-1-11 and UL 61010, ensuring they meet stringent safety standards for medical devices.
EMC Compliance
Certified with EN 61326-1, our devices comply with electromagnetic compatibility standards, ensuring reliable performance in various environments.
Wireless/Cellular Approvals
We have achieved certifications from PTCRB and comply with US FCC regulations, confirming our commitment to wireless and cellular standards.
Regional Compliance Overview
USA, Canada, and EU Compliance
In the USA, we comply with 21 CFR 820 and 21 CFR Part 11, ensuring adherence to FDA regulations and electronic signature standards. Our products are HIPAA compliant, safeguarding patient data privacy.
In Canada, we meet SOR 98-282 requirements and are registered with CAN Class I MDEL. Our commitment to PIPEDA compliance ensures data protection and privacy.
In the European Union, we comply with EU MDR 2017/745 and GDPR, maintaining high standards for medical device regulation and data protection. Our products are self-certified under EU Class I CE standards.
Discover Spencer Health Solutions
Unlock the potential of seamless medication management with Spencer Health Solutions. Dive deeper into our innovative medication management solutions designed to simplify healthcare delivery and enhance patient outcomes. Click below to explore how we can support your journey towards better health management.