Design Assurance LLC
Product Quality & Regulatory
Engineering Services
At Design Assurance LLC, we live by the motto "a device is a device" or "a product is a product". This means the system architecture of any, simple or complex, device can be broken down to modular representations that describe the various indenture levels of the system. This improves the changeability and scaleability of your products.
The design input phase is the MOST important for any new product development. Pair that with a robust risk management process and the rest of your new product development project is simply a 'plug and chug' activity from that point on. Too many people rush this phase and it really hurts post-launch; especially if you plan to perform any future design changes.
We are constantly thinking about the bigger picture and how the actions from today will have an impact five years down the road. We believe a systematic modular approach to both the design and design history file.
Design Control Services
-Full Service
-Design & Development Planning
-Development Schedule Mapping
-System Architecture Creation
-System Requirement Decomposition
-Sampling Plans and Sample Size Rationales
-Design Verifcation and Validation Strategy
-Development Lot Equivalency
Risk Management Services
-Full Service
-Risk Management Planning
-Risk Assessment Tools
-Risk Assessment Facilitation
-Post-Launch Monitoring
-Risk Management Review
Audit Services
-Internal & External Audits
-Design History Files (DHF) Assessments
-Risk Management Files (RMF) Assessments
-Device Master Records (DMR) Assessments
-Compliance / GAP Assessments
Remediation Services
-Design History Files (DHF)
-Risk Management Files (RMF)
-Device Master Records (DMR)
-Compliance to New Standards
-IVDR / MDR Compliance
-Audit Findings / Warning Letter Actions
-Muda (waste) Reduction
Process Control Services
-Full Service
-Master Validation Planning
-Process Mapping
-Control Planning
-Design Transfer
-Sampling Plans and Sample Size Rationales
-Quality Control (QC)
Other Services
-Acquisition Services
-Regulatory Services
-Quality System Services
-Sustainment Services
-Program/Project Management Services
-Clinical Trial Services
-Kaizen Facilitation & Leadership
-CAPA Services
Qualifications
Industry Experience:
Over 20 years combined experience in...
- Diagnostic Systems (IVD, CDx)
- Chemistry/Reagent/Biologic
- Hardware
- Software
- Plastics and Consumables
- Medical Devices
- Class II / Class B
- Class III / Class C
Regulation / Standard Experience:
-
FDA 820
-
ISO 13485
-
ISO 14971 + ISO 24971
- IEC 62304
- IEC 61010
- IEC 60601-1 and IEC 60601-1-2
- ISO 10993-1
-
IEC 62366-1
-
ISO 13640/23640 / EP25
- Clinical and Laboratory Standards Institute (CLSI) Guidelines
And many, many, more!
Certifications:
- Quality Engineer (CQE)
- Medical Device Auditor (CMDA)
- Quality Process Analyst (CQPA)
- Six Sigma Yellow Belt (CSSYB)
Contact Us
Please provide your contact information with a brief message. We will respond within 48 hours to schedule a time to discuss how we are able to support any of your product quality needs.
If you prefer to send direct email, please use info@designassurance.org.