Grey Cloud Consulting
Medical Device Electrical Engineering Consulting Services
Providing Electrical Engineering services, specializing in the medical device industry
Quality
Regulatory
Compliance
Process Validation
PCBA Manufacturing Site Transfers
Project Management
Component Engineering
Sustaining
Continuation
Supplier Quality
Design & Development
Products
On-body Injector for delivery of UDENYCA bio-similar
Activities
Regulatory
On-site (Netanya, Israel) guidance for FDA submission
*including dFMEA, SW FMEA, pFMEA, document GAP analysis, TMV, FAI, CAPA
Products
HyPeak
G3PRO
G3LITE
G3LAB
Vessels
Activities
PCBA Manufacturing Transfer
GAP analysis to establish compliance of products
Design sophisticated Safety/EMC test strategy to demonstrate compliance of all products
Products
2008x Hemodialysis Devices (HD)
Liberty Select Cycler (Peritoneal Dialysis)
Liberty PDx Cycler (Peritoneal Dialysis)
Activities
PCBA Manufacturing Transfer
28 PCBAs: PTSystems (Concord, CA) and OnCore (Fremont, CA); to OnCore (Tijuana, MX)
17 PCBAs: PTSystems (Concord, CA) and OnCore (Fremont, CA); to Jabil (Guadalajara, MX)
19 PCBAs: Jabil (Guadalajara, MX) to Jabil (Chihuahua, MX)
Component Engineering
Select, Qualify and Implement electrical and mechanical components
Cable Manufacturing Transfer
18 cables to Avnet (Nogales, MX)
28 cables to OnCore Interconnect (Tijuana, MX)
Products
2008x Hemodialysis Devices (HD)
Liberty Select Cycler (Peritoneal Dialysis)
Liberty PDx Cycler (Peritoneal Dialysis)
Activities
PCBA Manufacturing Transfer
28 PCBAs: PTSystems (Concord, CA) and OnCore (Fremont, CA); to OnCore (Tijuana, MX)
17 PCBAs: PTSystems (Concord, CA) and OnCore (Fremont, CA); to Jabil (Guadalajara, MX)
19 PCBAs: Jabil (Guadalajara, MX) to Jabil (Chihuahua, MX)
Component Engineering
Select, Qualify and Implement electrical and mechanical components
Cable Manufacturing Transfer
18 cables to Avnet (Nogales, MX)
28 cables to OnCore Interconnect (Tijuana, MX)
Products
2008x Hemodialysis Devices (HD)
Liberty Select Cycler (Peritoneal Dialysis)
Liberty PDx Cycler (Peritoneal Dialysis)
Activities
PCBA Manufacturing Transfer
28 PCBAs: PTSystems (Concord, CA) and OnCore (Fremont, CA); to OnCore (Tijuana, MX)
17 PCBAs: PTSystems (Concord, CA) and OnCore (Fremont, CA); to Jabil (Guadalajara, MX)
19 PCBAs: Jabil (Guadalajara, MX) to Jabil (Chihuahua, MX)
Component Engineering
Select, Qualify and Implement electrical and mechanical components
Cable Manufacturing Transfer
18 cables to Avnet (Nogales, MX)
28 cables to OnCore Interconnect (Tijuana, MX)
Products
Alaris (IV pump infusion set)
MiniMED (Insulin pump)
Activities
SQE representative for Alaris
NEO Project (Alaris PCU, Alaris Syringe, Alaris LVP)
Oridion Project (Alaris EtCO2 - Medtronic MiniMedCO2 redesign)
S2 Project (Alaris Syringe, Alaris PCU, Alaris LVP)
M2 Project (Alaris LVP, Alaris PCU)
Domestic and International Supplier Quality Audits
ISO 13485 / ISO 9001 Supplier Quality Audits
-
Metallux (Nellmersbach, Germany) - sensors
-
Dexter Magnetic Technologies (Elk Grove, IL) - magnets
-
Crescent Industries (New Freedom, PA) - plastic injection molding
-
Springfield Spring & Stamping (East Longmeadow, MA) - springs
-
Panasonic (Monterrey, MX) - PCBAs
-
Hitec Sensor Solutions (Littleton, MA) - sensors
Products
AIC (Automated Impella Controller)
Models: 0042-4000, 0042-4001, 0042-4003
-
System for use in controlling temporary femoral placed Impella pump for assisting in unloading blood from the left ventricle
Activities
Sustaining
Root Cause Corrective Action and Remediation on AIC Field Returns
Products
M710/M270 (Programmers)
M107/M108 (Implantables)
VNS Therapy Model 201 (Programming Wand)
Activities
Compliance
3rd Party Lab Safety, EMC and RTA Compliance Testing
-
TÜV SÜD America: New Brighton, MN and Taylor's Falls, MN
-
Northwest EMC (Plano, TX)
In-house Product Verification Testing
Products
REVIVE 2035/2036 (Critical Care Mattress)
InTouch Bed
Gaymar TP650-series and TP700-series (Syringe pumps)
Activities
Product Development
60601-1 and 60601-1-2 Testing
-
Stryker Instruments (Portage, MI)
-
LECO Corporation (St. Joseph, MI)
Design Improvements to overcome EMC issues
Compliance
60601-1 and 60601-1-2 Testing
-
TÜV Rheinland (Northbrook, IL)
Design Transfer
Gaymar (Orchard Park, NY) to Stryker Instruments (Portage, MI)
-
Complaint Investigations
-
DHF Reviews
-
Procedure Assessments
-
MDR Reviews
Remediation
GAP Analysis on Gaymar Syringe Pumps
-
60601-1, 3rd Edition and 60601-1-2, 3rd Edition compliance
Products
CDI 500
-
Extracorporeal Blood Parameter Monitoring System for use during aortic bypass surgery
Activities
Sustaining
-
DHF Remediation
-
GAP Analysis on document discrepancies
-
Update documentation
-
FDA Title 21 CFR Part 820 assessment
Design and Prototype
Electrical System used for verification testing
Verification and Validation
-
Validate Test Fixtures for use at vendor site
-
Create V&V protocols for product testing
-
Manage V&V at vendor site (Northbrook, IL)
-
Create results reports
Products
MIST Therapy
-
System that uses ultrasound and saline to accelerate wound healing
Activities
Electrical Design
Product improvement for detecting ideal treatment distance
Sustaining
Legacy MIST Therapy System
-
DHF Remediation
-
Risk Remediation
-
Trace Matrix and RPN creation
-
FDA Title 21 CFR Part 820 assessment
Next Gen Design
-
Manage 3rd Party Redesign
-
Analyze/Adapt legacy V&V protocols
-
Update DHF
-
Update Risk Documents
Products
LATITUDE Communicator
-
System that inductively interrogates cardioverter device and transmits information to Boston Scientific
Activities
Sustaining
-
Root Cause Corrective Action
-
Remediation on LATITUDE Returns
Products
CADD-Legacy PCA, CADD-Legacy PLUS, CADD-Prizm (Peristaltic pump)
Medfusion 3000/3100/4000/4500 (Syringe Pumps)
Graseby 300-series (Syringe Pumps)
Activities
Continuation
Root Cause Corrective Action on LATITUDE Returns
Design Transfer
Medex Medfusion acquisition transfer (Duluth, GA) to Smiths Medical (Arden Hills, MN)
-
Complaint Investigations
-
DHF Reviews
-
Procedure Assessments
-
MDR Reviews
-
FDA Title 21 CFR Part 820 assessment
Sustaining
Graseby DHF EMC Gap Assessment in Watford, UK
-
FDA Title 21 CFR Part 820 assessment
Continuation
-
Complaint Investigations on CADD field returns
-
Designed and implemented microcontroller-based power control system to aid in inducing failure recurrences
-
Implemented ESS methodologies to assist in replicating intermittent failures
-
