Quality & Regulatory Compliance

You Need to Ensure Quality and Regulatory Compliance

Quality & Regulatory Compliance

We analyze product requirements, specifications, and options; verify that components are properly integrated; provide evidence of performance; and certify specification compliance.

We keep abreast of all the safety and compliance requirements in the regions of the world, ensuring that the products we purchase on behalf of our customers meet the compliance requirements for the countries where they do business.

Range of Medical Devices We Cover:

In Vitro Diagnostics
Lab Automation
Diagnostic Devices
Imaging Devices
Surgical Devices

Our capabilities include:

Quality Assurance

Focus on Continuous Improvement
Pre-validation Testing Documentation
Corrective and Preventative Action (CAPA) Process
Root Cause Analysis
Failure Mode and Effects (FMEA) Analysis

Regulatory Compliance

Adherence to Global Regulatory Requirements
Product documentation for Reach, RoHs, CE, CCC, BIS and others
Investigation and validation for Country of Origin
ISO 13485 Registered
Document Control-Device Master and Device History Records Maintained

Why Dynamic?

Quality Assurance

We provide documentation for pre-validation testing, detailing how every aspect of a product or component meets customer needs.
We regularly inspect incoming and outgoing products for defects and non-conformance.
We have a formal process to manage corrective and preventative actions (CAPA) and are focused on continuous improvement.

Regulatory Compliance

What clients say...

“Dynamic has been a valued and trusted partner for decades. Their deep understanding of technology is a tangible asset for their clients."
Partner Business Manager

“Dynamic provides a comprehensive portfolio of leading solutions and services to meet the evolving needs of any client for any market. We are proud to partner with them."
Senior Manager - Named Accounts

“I received my devices, and was up and running in record time. Your process works great! Nice work on everything. This process is very efficient and incredibly easy to operationalize a new device."
Chief Technology Officer

“I want to express my personal appreciation for all of your help. Thank you for everything you're doing for us. We're truly grateful."
Senior Vice President - Information Systems

“Communication, flow and response time are really good. I appreciate their willingness to learn our internal product lifecycle process. I always feel an intent to do the right thing from Dynamic."
Senior Manager of New Product Introductions

“Our EOL management has improved drastically with Dynamic's 24 hour notification of parts going EOL, and with monthly reviews of action items. Their customer portal with real-time data is also very helpful."
Senior Manager - Direct Procurement

“Dynamic has gone above and beyond to communicate critical issues, to understand our processes and procedures, and to comply accordingly."
Director of Instrumentation Software Development

“I believe this is the first time that I have ever received a supply chain risk assessment like this from any supplier."
Senior Procurement Manager - Direct Electronics

"Dynamic provided the exact combination of technology and non-technology-related components required. The risk of downtime and failure was mitigated by tightly managing the BOM and ensuring FDA standards to optimize the supply chain. There have been zero product defects since the product launch in 2014."
Medical Device Manufacturer

These endorsements do not identify client names, to honor confidentiality agreements.