Class 7 Clean Room

Class 7 Clean Room

Our cleanroom is ISO 14644-1:2015 Class 7 certified to provide the proper controlled environment for packaging of finished devices. Manufacturing and assembly of components and devices also take place in the Class 7 environment, where appropriate. Our cleanroom is monitored and maintained per ISO 14644-2:2015.

We currently have over 3,500 square feet of cleanroom space, with dedicated space to expand to over 5,000 square feet of cleanroom space in a matter of weeks. ‍

Manufacturing Transfer for Medical Devices

Our cleanroom is ISO 14644-1:2015 Class 7 certified to provide the proper controlled environment for packaging of finished devices. Manufacturing and assembly of components and devices also take place in the Class 7 environment, where appropriate. Our cleanroom is monitored and maintained per ISO 14644-2:2015.

We currently have over 3,500 square feet of cleanroom space, with dedicated space to expand to over 5,000 square feet of cleanroom space in a matter of weeks. ‍

Track 1

Understanding
Customer
Needs

The first step in a successful manufacturing partnership is fully understanding the customer needs. Based on initial program feedback from our clients, we coordinate a call with the appropriate MIS experts to gain a comprehensive understanding of the scope of the manufacturing transfer and to identify a clear path forward to ensure we meet the client’s needs. By executing on Track 1 deliverables, a clear path is outlined on how to successfully drive the manufacturing transfer to completion. The activities in this initial track include:

Align timelines

Review prints

Assess capabilities

Assess suppliers

Design for manufacturing opportunities

Align inspection methods

Assess equivalency

Review COGS

Analyze supply chain efficiencies

Testing strategy

Generate proposal

Track 2

Process Equivalency

The second track in our Manufacturing Transfer Process is Process Equivalency. MIS Engineering and Manufacturing teams’ partner during this phase to begin process development while ensuring all device requirements are met. At the completion of this phase, MIS will provide a process equivalency report demonstrating the MIS design and processes are substantially equivalent. Activities in this track include:

Confirm timeline

Draft component and assembly level documentation

Draft MPIs, routers

Equipment transfer/equipment equivalency studies

Order or transfer material, tooling

Process development

Process equivalency testing

Track 3

Process Validation

The third track in our Manufacturing Transfer Process is Process Validation. These activities are driven by customer certification requirements that are non-verifiable. While it is most common to execute Process Validation, MIS is also able to support lot release testing for product release and certification to meet our customers’ needs and cost targets. The deliverables we complete during this phase typically include:

Draft OQ/PQ plans

Product builds

Execute OQ/PQ testing for processes

Generate reports

Track 4

Transfer to Production

The fourth and final track in our Manufacturing Transfer Process is Transfer to Production. This phase is dedicated to production preparedness. Upon completion of this track, MIS continues support of the production line with planned ramp strategies, aggressive OEE targets, and a robust VIP program to achieve short- and long-term cost targets. Activities in this phase include:

Production line assembly

Pilot manufacturing

Onboarding and training line resources

Production ramp plan

Draft control plan

Download our Manufacturing Transfer Guide

Contact Us Today about your

Class 7 Clean Room
needs!
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Shop Our Products.