Clearances and Compliance Documents

Quality Policy

Northeast Scientific, Inc. is dedicated to complying with all requirements, maintaining the effectiveness of the Quality System, and providing our customers with the highest level of quality products. Effective management and committed employees working together enables NEScientific to accomplish this goal.

Our customer-centric and high-quality approach focuses on regulatory and quality compliance in order to deliver products that ultimately help our customers and NEScientific deliver safe, cost-effective, and reliable healthcare to their patients. Reviewing NEScientific’ quality objectives and setting new goals will ensure NEScientific maintains the effectiveness of the Quality System (the quality objectives can be found in CM-1029 Northeast Scientific, Inc. Quality Manual).

NEScientific is ISO Certified

Successful partnerships are a two-way street that depend on quality and consistency every step of the way. The ISO 13485:2016 offers another reason you can count on Northeast Scientific to deliver just that.

Key requirements under ISO 13485:2016 certification include:

Maintenance of a comprehensive design history for each manufactured device

Validation of contamination control processes for sterile medical devices

Monitoring and measurement for complaint handling and regulatory reporting

A clear definition of specific skills and experience of quality management personnel, plus verification of ongoing training effectiveness

Formal processes for obtaining and incorporating production and post-production feedback into risk management programs

Deep validation of quality management system software

What this means for partners like you

“ISO 13485:2016 is another part of how Northeast Scientific has reinforced its position in the market for setting the standard for quality and consistency in the remanufacturing space. We firmly believe that we are able to give the Doctors who purchase our remanufactured devices peace of mind knowing that we coupled the ISO 13485 Certification with the rigors of the FDA 510(k) process to get them devices equivalent to the OEM at a huge cost savings.”

– Matt Farley, Director of Quality and Regulatory Engineering.