Quality Policy

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 Northeast Scientific, Inc. Quality Manual).

NEScientific participates in the Medical Device Single Audit Program (MDSAP)

Successful partnerships are a two-way street that depend on
quality and consistency every step of the way.The MDSAP shows we deliver just that.

By adhering to the strict requirements of MDSAP we are conforming to the requirements of ISO 13485:2016 which call for:

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

NEScientific ISO 13485 Certificate

What this means for partners like you

“MDSAP is another part of how Northeast Scientific has reinforced its position in the market for setting the standard for quality and consistency in the reprocessing space. We firmly believe that we can give the doctors who purchase our reprocessed devices peace of mind, knowing that our Quality system meets the stringent requirements of ISO 13485 Certification through MDSAP to get them devices at a huge cost savings,”

– Matt Farley, Director of Product Development and Interim Director of Quality and Regulatory