Standards Programs

Standards Compliance: The Easiest Way to Ensure Safety and Meet Regulations

On-Site Training in the Application of Product and Process Standards From:

· IEC

· ISO

· CEN

· CENELEC

· AAMI

· Most other major standards development bodies around the world

Special programs

· Monitor and report on the content of selected standards, revisions and amendments for impacts to your products and processes

Compliance evaluations of products and processes with Recognized (US) and Harmonized (EU) and broadly accepted International standards:

· ISO 14971 - Risk Management

· IEC/EN 60601-1 series - Electrical safety and essential performance, Programmable Electrical Medical Systems, Medical Electrical Systems, EMC, device specific (particular) standards

· AAMI HE 48 - Human Factors

· Many more…

Development of Standards Compliance Strategies

· For new products (tactical) or for the entire organization (strategic)

· For updating product lines to new or revised standards

Provide all of the compliance Services normally available only in large organizations:

· for small manufacturers

· start-ups

· entrepreneurs

Facilitate Risk Analyses and ongoing evaluations of your products and Risk Management processes required by ISO 14971.

Monitoring and Maintaining Compliance Certifications and Marks Licenses with Compliance Certification Bodies

· Determining the best Certification Body and Certification type (marks license/ Certified Body report) for your organization's needs

· Provide advocacy/representation with Certification Bodies

· Review of design changes for impact on certifications & coordination of report updating activities to maximize efficiency and minimize costs

· Manage overall continuing compliance processes

Managing and organizing participation in standards development activities

· Tracking of documents available through industry associations and analyses of their impacts to your organization with comment and vote recommendations.

· Coordinate participation in standards development by your personnel

· Development of coordinated responses from your organization on draft standards