Medical Device QMS Certifications

By: MethodSense, Inc  08/04/2015
Keywords: Process Improvement, Business Process Management, Business Process Improvement

ISO 13485 Quality Certification is required for medical device companies as a qualification to market medical devices in most non-US markets. Like all quality standards, ISO 13485 requirements can, if implemented incorrectly, create unnecessary inefficiencies and costs. MethodSense's experience ensures your adoption of ISO 13485 leverages your current FDA compliance efforts or is implemented in the most practical way possible. MethodSense's successful ISO 13485 implementations have: • Improved operational efficiency • Reduced audits • Enhanced marketing efforts • Promoted international trade • Increased profits • Met increased demand from customers • Improved internal management of QMS

Keywords: Biotech Consulting, Biotechnology Consulting, Business Process Improvement, Business Process Management, Industry Specialist Consultants, 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.


Quality Assurance Consulting

At MethodSense, we’ve developed practical regulatory solutions which allow you to meet high levels of product quality and auditability.


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.