Our quality commitment

Rolenn Manufacturing’s Quality Team has extensive experience with the demanding requirements for the Aerospace and Medical Device industries and uses a range of methods and tools to support elements of the Quality System such as Process Development, Product Realization, Risk Management and mitigation strategies.

Rolenn Manufacturing has established, documented, and implemented a quality management system which is continuously reviewed and evaluated for effectiveness in accordance with ISO 9001, ISO 13485, FDA QSR 21 CFR part 820.

  • cGMP and QSR compliant globally

  • ISO 9001 certification

  • ISO 13485 certification

  • ISO Class 7 & 8 Cleanrooms

  • Climate-controlled inspection laboratory

  • Test method development, first article inspections, Gauge R&R

  • Process Validations (IQ, OQ, PQ)

  • Electronic Record Keeping

  • ISO 9001 Certificate
Testing
Polymer Testing

We perform post-production testing following the
ASTM D2240 standards.

This test method covers twelve types of rubber hardness measurement devices known as durometers: Types A, B, C, D,DO, E, M, O, OO, OOO, OOO-S, and R.

Qualifications

We want to give you the peace of mind of being delivered with fully operational products.

We have a high degree of assurance in our manufacturing process and with our experience we are able to provide qualifications for a new product line very shortly.

IQ
OQ
PQ
Certified Clean Rooms
Class 7 and 8 Clean Rooms

When contamination is a risk, our clean rooms can fulfill your needs for safe molded products

 

Rolenn Manufacturing

1-951-682-1185