Regulatory Assessment SaMD US/EU
CUSTOMER SITUATION
The Customer is a US based software company who recently involved in medical device industry to develop software for clinical study and patient enhanced experiences. They are seeking a quality and regulatory consultation support for FDA and CE compliance while they developing variety for software to be used either alone or in conjunction with other approved medical devices, like ECG, glucometer, blood pressure monitor, smart watches, etc.
CUSTOMERA US based Software Company
GOALSUS and EU compliance
Integrator
Regulatory assessment on US and EU regulations; Map up SOPs for software development
Zi-medical Solution
Zi-medical has track record of obtaining 100% clearance from FDA for medical devices under 510(k) applications and familiar with SaMD requirements in both US and EU. Zi-medical worked closely with client to conduct regulatory assessment on each type of products, defining product categories and regulatory requirements, drafting quality procedure for software development based on US and EU requirements.
Zi-medical Services including following steps:
US Regulatory Assessment
- Regulatory assessment
- Registration requirement and timeline
- Registration preparation and submission
EU Regulatory Assessment
- Regulatory assessment
- Registration requirement and timeline
- Registration preparation and submission
Quality Compliance and Software life cycle development
- Gap analysis on quality system
- Software life cycle development procedure update and templates
- Internal audit
- Process Optimization
- Technical File Preparation and review for software products
HIPAA compliance and Cybersecurity assessment
- HIPAA guidance and gap analysis
- Drafting SOPs for HIPAA implementation
- Cybersecurity assessment and SOPs
Key Points
Zi-medical's experience with similar devices had enabled client to speed up the software development process to avoid time and money waste. Optimized software development process gain trust from client and enables high performance and quality compliance for product delivery;
Our expertise in HIPAA and Cybersecurity area gives strong advice and guidance to client to ensure software safety and efficacy.
Boston, MA, USA
+1 206.981.0675
mingzi@zi-medical.com