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Quality Engineering Services

Quality is sometimes overlooked in product development, especially in early design and development. At Neuma, quality is taken into consideration from the earliest stages of concept generation and continuously considered through development and commercialization. This is done by having a quality-centric culture focused on producing a safe and robust product.

Quality Engineering

By including quality from the beginning, quality is built into the device which reduces the likelihood that significant design changes will be needed. If areas such as how requirements will be tested, what standards the device needs to be compliant with, and how risks are assessed throughout the product development are not thought of early on, it can negatively affect the timeline. Quality Engineering at Neuma provide these services, along with others listed below, by being an integral part of the process.

                

  • Unambiguous and verifiable requirements

  • Requirements reflect applicable standards

  • Failure Mode and Effects Analysis (FMEA) creation, review, and use in development

  • Risk traceability (FMEA > Inspection > Verification and Validation (V&V))

  • Strategic planning to reduce sample size

  • Statistical approach to sample sizes (V&V, Tool/Process Validation, Inspection)

  • ANSI Sampling (Z1.4 and Z1.9)

  • Traceability Matrices (Design Inputs > Design Outputs)

  • Design History File (DHF), Device Master Record (DMR), Device History Record (DHR)

  • How our work fits into the larger DHF

Quality Management System

All Neuma employees have worked within Quality Management Systems (QMSs) that were compliant to ISO 9001, ISO 13485, ISO 14971, and various parts of 21CFR. Neuma has quality tools which allow us flexibility to work under design controls within your QMS. Our quality tools are being structured after ISO 9001 with the intended capabilities:

  • Revision Control

  • Revision History

  • CAD/Document Review/Approval

  • Prototype Release

  • Archive Projects

  • Electronic Signature

  • Unique Document Identification

  • Maintain Equipment Calibration

  • Maintain Part Traceability

  • Easily create custom build configurations and maintain traceability

  • Flexibility to work within a customer’s QMS

Neuma is also familiar with a variety of standards/regulations which may be applicable based on your product.

  • IEC 60601

  • IEC 60529

  • IEC 62304

  • ISO 10555

  • ISO 10993

  • ISO 11607

  • ISO 11608

  • ISO 11040

  • USP 660

  • USP 787

  • USP 788

  • REACH

  • RoHS2