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Quality Presentation�

June 7, 2024

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Global Capabilities for End-to-End Support

Founded in 1953

17 companies
41 locations globally
2,300 employees

Ascential MLS Locations

North America

Ada, MI
Corvallis, OR
Sturtevant, WI
Auburn Hill, MI
San Diego, CA
Three Rivers, MI
Grand Rapids, MI
Shelby Township, MI
Ham Lake, MN
Blaine, MN
Sonora, CA

Central America

San Jose, Costa Rica

South America

Sao Paulo, Brazil

Ireland

Limerick

Singapore

Malaysia

Johor Bahru

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Ascential Medical & Life Sciences

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Ascential’s MLS Group partners with leading companies to design, build, and automate scaled production of complex medical devices, instruments, and associated consumables.

Our reputation is built on leveraging unparalleled global product realization capabilities with world-class automation heritage to comprehensively solve our client’s most challenging problems and achieve their commercial goals.

Automation

DIVISIONS

BUSINESS UNITS

PARENT COMPANY

Life Sciences

Medical Devices

Ascential

Medical & Life Sciences

Transportation

Industrial

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Quality & Regulatory Certifications – San Diego

FDA Registered (# 3005268307)

21 CFR Part 820 & Part 11 Compliant

ISO 13485:2016 Certified (# MD 793157)

Scope - Contract Services for the Design, Development, Manufacture, and Servicing of Non-Sterile Electromechanical Diagnostic and Therapeutic Medical Devices

California Medical Device Manufacturing Licensed (# 121465)

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Ascential San Diego

Ascential Product Commercialization

Ascential Quality

Proven track record with clients

10+ years manufacturing medical/IVD devices

No recalls
No 483s
No Consent Decrees

Deep engineering expertise

13+ years medical/IVD device development, and design Xfer
100+ engineers, co-located w/ all disciplines trained in QMS
Demonstrated track record in

Root-causing, problem solving, and implementing appropriate changes
Remediating design & documentation issues inherited from other suppliers
Collaborating w/ quality, manufacturing, supply chain and our clients

Experienced core team drawn from top 20 Medical device companies, averaging more than 15 years' experience.

Well-rounded team with the technical, quality, & operational expertise to successfully execute the Alinity m design transfer & scale to volume production.

Existing strong working relationships between our two teams, stretching across all functions.

Quality/Regulatory expertise. Skilled in remediating documentation and configuration gaps.

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Quality Team - San Diego

Experienced Quality Team

106+ combined years of experience in medical devices and in vitro diagnostic devices

Crucial FDA experience from pre-submission through routine inspections

Valuable experience with ISO, IVDR/MDR, MDSAP, GAMP, GDPR, ICH

Product and Process Lifecycle experience from development through commercialization

Industry leading technology/design transfer experience

Experienced quality team drawn from Abbott, J&J, Boston Scientific, Medtronic, and Dexcom

Regular cross-site collaboration between Ascential MLS Quality Teams

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Quality Continuous Improvement

Optimized Lean Manufacturing process
Ascential Production System (APS) implemented Oct-2023

Continuous regulatory compliance improvement of the Quality Management System, including implementation of EU IVDR 2017/746 and EU MDR 2017/746

QMS 2.0 Quality Plan (D011251) near completion (30-Jun-2024 due date)

Implementation of industry leading eQMS (ETQ Reliance)

eQMS Implementation Quality Plan (D013174) near completion (31-Oct-2024 due date)

Implementation of a new state of the art Manufacturing Execution System (MES-Visual Factory)

MES Implementation Quality Plan (D013458) in process (Q3-2025 completion)

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Quality Mangement System - San Diego

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Robust QMS

FDA Registered & ISO 13485 Certified QMS

Includes validated ERP System & eQMS System

Management Responsibility & Commitment

Quality Manual & Policy
Mangement Reviews

Resource Management

Training
Certifications
Performance Evaluations

Documentation Requirements

Change Control
Control of Records
Periodic Reviews

Purchasing Controls

Supplier Qualifications
Supplier Monitoring & Corrective Actions
Part Qualifications
Materials Compliance (Reach, RoHS, Conflict Minerals, etc.)
Receiving Inspection

Design Controls

Design & Development Planning
Design & Development Input
Design & Development Output
Design Reviews
Design Verification
Design Transfer
Risk Management
Design History File (DHF)

Production Controls

Manufacturing Process Validations
Work & Test Instructions
Label Control
End of Line Testing
In-Process & Final Quality Inspections
Quality Release
Device History Records (DHR)
Device Master Record (DMR)

Infrastructure

Safety
Facility Controls including Pest Control
Warehouse & Materials Controls

Equipment Controls

Equipment Qualification
Preventative Maintenance
Calibration

Monitoring & Measurement

Internal Audits
Annual ISO Surveillance Audits
Quarterly NRTL Audits
Customer Feedback
Customer Complaints/SCARs
Planned Deviations
NCRs
CAPAs

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Life Sciences

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Instrument Development �& Production

Alinity m Estimate for Quoting:

~1500 Part Numbers

~5000 Parts Total

Sample Prep

843 Part Numbers

4392 Parts Total

Oligo Synthesis System

2369 Part Numbers

7546 Parts Total

AST Analyzer

1522 Part Numbers

6713 Parts Total

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Trusted by leading brands

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INSTRUCTIONS FOR USING THIS SLIDE:

If you need to update the icons, you can click the icons and delete them and replace them with icons of your choosing.
For body text, use the indent button on the Home Tab to get to the second layer of styling.

Drag and drop photos into the image placehoders.
Alternatively, you can click on the image silhouette and use the file manager to navigate to the image you’d like to add.
To replace an image, simply select the image you want to remove and hit [DELETE] on your keyboard. Then add a new image as described above.
If you need to reset the slide, you can select the HOME tab, and select “Reset” next to the New Slide button.

If you need to crop an image, you can select it, right click and select the option to CROP. You can then adjust the crop to suit your needs.