onQ Management Consulting LLC, with an industry leading consultanting team, will provide you a one stop shop for Quality & Regulatory services.
Medical Device Consulting Services offered:
-Quality & Regulatory Strategy development
-Organizational & Leadership development: Analysis, planning and
structure development.
-Regulatory compliance to FDA & global MOH requirements:
development and implementation of quality management systems
compliant to ISO13485, FDA QSR, CMDR, ANVISA etc. Includes
development of corporate policy and system to deploy down to the
division, regional, and local level:
-Design Controls Program
-Production and Process Controls Program
-Purchasing Controls / Supplier Quality
-Service Quality Program
-CAPA
-Complaints Management / Adverse Event Reporting
-Management Responsibility / Review
-Compliance audits and gap assessments to FDA QSR and global
regulations
-483 / Warning Letter / Consent decree remediation planning &
support
-Risk Management program (ISO14971)
-Product quality and reliability improvement utilizing six sigma tools
-CE marking to market products in the EU
-Process Validation
-Six Sigma / lean program development and deployment
-Recall strategy, planning and resourcing
-Acquisition Due Diligence, planning and integration (Quality &
Regulatory)
-US FDA Agent Representative in US for companies with no US
presence
-Quality system tools and IT integration
-Board of Directors support in Quality and Regulatory Compliance matters
-Retainer services
-Strategic Analysis (SWOT): Failures in the area of regulatory
compliance, product quality and quality systems.
-Business Development: Provide sales / business development
support to other Medical Device Consulting businesses that need this
type of service.
Company Details
- Employees
- 1
- Founded
- -
- Address
- Orlando, Florida 32836, Us
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- http://www.onqconsult.com
- Keywords
- offered:.
- HQ
- Orlando, Florida
Onq Management Consulting Llc Questions
Onq Management Consulting Llc's website is http://www.onqconsult.com
Onq Management Consulting Llc's LinkedIn profile is https://www.linkedin.com/company/med_device
Onq Management Consulting Llc has
1 employees.
View email and phone details for 1
employees at Onq Management Consulting Llc.
Onq Management Consulting Llc's industry is
Medical Equipment Manufacturing
Onq Management Consulting Llc's top competitors are
Regulatory Compliance Consulting, Llc,
Onq Performance Consulting,
Mddx Solutions, Llc,
G2 Consulting Services, Inc,
Qes Medical Llc,
Integrity Quality Consulting, Llc,
Acknowledge Regulatory Strategies,
Iteam Forward,
Qualis-Solutions, Llc,
Regulatory Technology Services.
Onq Management Consulting Llc's categories are Medical Equipment Manufacturing
Onq Management Consulting Llc's founding year is 2017
