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ISO 13485

ISO 13485

Achieve ISO 13485 Certification ISO 13485 is a Quality Management System standard designed for medical device companies. Being ISO 13485 compliant shows a commitment to the safety and quality of your medical devices. Documented compliance to an ISO Standard, even in...
21 CFR Part 820

21 CFR Part 820

FDA 21 CFR Part 820 Compliance Solutions Medical device manufacturers must establish quality systems and design controls to ensure their products meet applicable requirements and do not pose unacceptable risk to the consumer or public. FDA 21 CFR Part 820 is the...
good manufacturing processes

good manufacturing processes

21 CFR Part 820 – Good Manufacturing Processes for Medical Devices If you manufacture a medical device, the FDA will require that your quality system meet the Quality Management System Regulations of 21 CFR Part 820, which outlines the current Good Manufacturing...
iso compliance

iso compliance

ISO Compliance for Medical Device Companies ISO compliance for medical device companies demonstrates that International Organization for Standardization (ISO) guidelines are followed. Global commercialization of your medical device most often requires ISO 13485...
QMS

QMS

Quality Management System Consulting for Medical Device Companies The FDA requires medical device companies to follow cGMP requirements and implement a Quality Management System (QMS) that demonstrates 21 CFR Part 820 compliance. This includes regulations for...
on-call quality support

on-call quality support

Easily Maintain Compliance On-Call Quality Support is a unique pairing of our software – with all its controls – and our decades of experience as quality and regulatory consultants.  For a proven way to reduce risk and costs, get fast results and get the most...
quality certification

quality certification

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 markets. Like all quality standards, ISO 13485 requirements can, if implemented incorrectly, create...
quality assurance

quality assurance

Essential Quality Processes 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...