Regulatory Assessment SaMD US/EU

01/21/2021


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.

CUSTOMER

A US based Software Company

GOALS

US 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