Quality Assurance Consulting

By: MethodSense, Inc  08/04/2015
Keywords: Process Improvement, Medical Device Companies, Regulatory Consulting

Regulatory agencies, by law, require the implementation of Quality Management Systems to preserve public safety and ensure the manufacture of licensed or cleared products. When implemented properly, Quality Management Systems enable you to operate as a medical device or life science company, while achieving the auditable standards necessary to market your product. At MethodSense, we’ve developed practical regulatory solutions which allow you to meet high levels of product quality and auditability. Our experience spans: • Quality Management Needs and Gap Analyses • Quality Management System Creation and Implementation • 21 CFR Part 820, ISO 13485, 14971, 9001 and more • Certification Management and Follow Up • GAMP • cGMP • Quality as a Service • Facility Readiness

Keywords: Biotech Consulting, Biotechnology Consulting, Medical Device Companies, Medical Device Consulting, Pharmaceutical Consultants, Pharmaceutical Consulting, Process Improvement, Regulatory Consulting

Other products and services from MethodSense, Inc


Data Integrity Management

From 21 CFR Part 11 to AlCOA, MethodSense can help you practically implement the processes and plans designed to both achieve compliance and support data integrity.


Software Safety Testing and Software Validation

MethodSense mitigates your risk by ensuring key business systems and product technologies function as intended and comply with regulations.


Life Science Safety Testing Management

Rita King, our CEO, participated in the development of safety critical software standards for UL and ANSI, giving us key insight into how certification is achieved.


Medical Device QMS Certifications

ISO 13485 Quality Certification is required for medical device companies as a qualification to market medical devices in most non-US


Regulatory Affairs Consulting

Our regulatory professionals work with you to develop and execute a roadmap to commercialization by ensuring you meet the evidentiary requirements that demonstrate the safety and efficacy of your medical device. Our experience covers regulatory requirements of the US, Canada and Europe.