Harnessing science and technology to save lives.
Quality and Regulatory Compliance
Trusted by leading brands
Ascential Medical and Life Sciences is deeply committed to advancing healthcare and improving patient outcomes through innovation in science and technology. This includes delivering products and services that meet the highest standards of quality. Our commitment is embedded in every aspect of our operations across more than 40 facilities worldwide.
Ascential’s state-of-the-art facilities maintain rigorous quality standards that are regularly evaluated through internal audits, regulatory reviews, and customer feedback to ensure continuous improvement and compliance.
Our mission is to support our customers in bringing superior medical innovations to market efficiently. By placing patient safety and product efficacy at the forefront of our priorities, we aim to improve health outcomes and drive industry standards forward. Our team works to foster industry-leading practices, deliver exceptional value to our customers, and improve lives worldwide.
We understand the responsibility that comes with manufacturing and developing medical products, and we are committed to upholding the trust placed in us by our customers, clinicians, and their patients. Ascential is your trusted partner, committed to excellence in every product and process we design.
Certifications
Our manufacturing sites are certified to the following standards:
| Country | Location | Division Name | ISO 9001 | ISO 14001 | ISO 13485 | FDA Registered | California Medical Device Manufacturing Licensed |
|---|---|---|---|---|---|---|---|
| USA | Blaine, MN | Aspect Automation, LLC | Download | ||||
| USA | San Diego, CA | D & K Engineering | Download | Download #MD793157 |
#3005268307 21 CFR Part 820 & Part 11 Compliant |
Download #121465 |
|
| USA | Ham Lake, MN | NACS Inc. | Download | Minnesota Board of Pharmacy | |||
| USA | Corvallis, OR | Korvis LLC | Download | Download | |||
| Singapore | Singapore | Ascential Singapore | Download | Download | |||
| Malaysia | Malaysia | Ascential Malaysia | Download | Download | Download |
| Certification/Compliance | Details |
|---|---|
| FDA Registered | FEI Number 3011026927, Establishment Registration & Device Listing |
| Minnesota Board of Pharmacy | Details at MN Health Board (Search License #461991) or Download |
| 21 CFR 210/211 Compliant | Details - Part 210, Details - Part 211 |
| 21 CFR 820 Compliant | Details |
| 21 CFR Part 4 Compliant | Details |
| 21 CFR Part 11 Compliant | Details |
| State of California Department of Public Health Medical Device Manufacturing License | Download |
More Resources
Your Trusted Partner for Seamless Medical Innovation
Ascential Quality
- Experienced core team drawn from top 20 Medical device companies, averaging more than 15 years' experience.
- Well-rounded team with the technical, quality, and 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.
Ascential Product Commercialization
- 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 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
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)
Robust QMS
- FDA Registered & ISO 13485 Certified QMS
- Includes validated ERP System & eQMS System
- Management Responsibility & Commitment
- Quality Manual & Policy
- Management 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