Scope of Services
Our philosophy is to work closely with the client early in the project timeline to provide the most cost effective product design, manufacturing and regulatory strategy.
TCS (www.tcs-gxp.com) structures its validation and quality programs to the client’s needs. Whether you are required to meet local or corporate policies, we provide the staffing to meet your needs for such services as:
TCS (www.tcs-gxp.com) structures its validation and quality programs to the client’s needs. Whether you are required to meet local or corporate policies, we provide the staffing to meet your needs for such services as:
General Consulting Product Development Lifecycle (HW & SW) Regulatory Strategy Clinical Evaluation and Planning Project Management |
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Product Development Lifecycle
Design Development Planning from Concept to Commercialization
IEC 62304 Evaluation and Planning
Direct and Indirect Computer System Validation
Risk Management per ISO 14971
Cyber Security Planning
ProdSec and InfoSec
QMS implementation
Supplier Evaluation and Qualification
Internal Audits
Part 11 compliance assessment and Validation
Supervisory Control and Data Acquisition System (SCADA)
Management Execution System (MES)
Building Automation / Management System (BAS/BMS)
Laboratory Information Management System (LIMS)
DAQ Station (DXP) Thermal Continuous Monitoring / Data Acquisition / Alarming System
Pilot Production & Scale Up
IEC 62304 Evaluation and Planning
Direct and Indirect Computer System Validation
Risk Management per ISO 14971
Cyber Security Planning
ProdSec and InfoSec
QMS implementation
Supplier Evaluation and Qualification
Internal Audits
Part 11 compliance assessment and Validation
Supervisory Control and Data Acquisition System (SCADA)
Management Execution System (MES)
Building Automation / Management System (BAS/BMS)
Laboratory Information Management System (LIMS)
DAQ Station (DXP) Thermal Continuous Monitoring / Data Acquisition / Alarming System
Pilot Production & Scale Up
Regulatory Strategy
Regulatory Planning
Regulatory Submission (PMA, De Novo, 510k, SaMD, 513g, Q-Sub, CE Mark, ISO 13485, EU MDR, EU IVDR & MDSAP)
Regulatory Submission (PMA, De Novo, 510k, SaMD, 513g, Q-Sub, CE Mark, ISO 13485, EU MDR, EU IVDR & MDSAP)
Clinical Evaluation and Planning
CRO Collaboration
IRB Approval
Clinical Site Audit
TMR Preparation
IRB Approval
Clinical Site Audit
TMR Preparation
Project Management
Develop Project Gantt Chart and Tracker
Phase Review
Management Review
Design Transfer
Phase Review
Management Review
Design Transfer
