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ISO 13485 | Medical Devices Quality Management | MD 69713

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ISO 13485 | Medical Devices Quality Management | MD 69713

For reasons of confidentiality this video was not filmed at UPC.

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We generate Wealth and IPR using a combination of Medicine, Science and Engineering.

UPC has a reputation for integrity, and works with similarly-minded partners generating wealth by making innovative and robust products, including associated laboratory and process equipment.

UPC-developed product sales revenue in 2021 was an unaudited £20,000,000,000 (15 years cumulative).

Over our 23 year history we have got the majority of our customers products to market – providing excellent returns on their R&D investment.

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Symbicort Rapihaler®

Breath Activated Inhaler & Counter

Primary Drug Container Integrity

Diabetes CSII Patch Pump

RTA Reconstruction

Foil Critical to Quality

UPC Design & Manufacturing

Green Propellant

Verified Prediction

Rapid Wound Healing System

Automation

Autoinjector

Autoinjector Platform

Medical Matters Blog

What UPC Offer

22 years of innovation, data & analysis creating wealth and IPR. Our services are:
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Product Consultancy
-Business Start-up services
-Patent support
-Managing innovation
-New Product Development
-Device services
-Regulatory Approval
-Product Industrialisation
Explore Further
Engineering Consultancy
- 1st principles Engineering
- New Product Development
- Drug delivery systems
- Sustainable life-cycle
- Root cause investigations
- Forensic investigation
- Testing and analysis
- Quality Strategy
Explore Further
New Product Development
- Project planning
- IP generation
- RMP, FTA, FMEA u,d&p
- Quality Strategy
- POP Models & Prototypes
- Predictive Modelling
- Design verification
- Approvals CE, CA, MDD, CFR
- Product Industrialisation
Explore Further
Drug Delivery Systems
- Medicines - treatment options
- Nasal Spray PDC
- Injectables & Inhalers
- Pumps - Patch & Syringe
- Disease Monitoring
- Regulatory approvals MDD
Explore Further
Sustainable Life Cycle Products
- Global warming potential
- Climate change
- Carbon life-cycle analysis
- Light-weight design
- Lower carbon emissions
Explore Further
Root Cause Analysis
- Novel design-led method
- FTA, FMEA
- Testing and analysis
- Predictive modelling
- Industrialisation review
- Quality Strategy
Explore Further
Ultra-Reliability QMS
- Experience derived QMS
- Ultra-reliable device method
- Embedded FTA, FMEA @ start
- Quality Strategy throughout
- Patient safety champion
Explore Further
Predictive Modelling
- UPC unique 6σ approach
- CTQ driven method
- Dimensional class by CTQ
- Function block models
- Stepping models - time, etc.
- Physics & Verification models
Explore Further
Forensic Witness
- Accident reconstruction
- Dispute resolution
- Patent, Trademark
- Civil versus Criminal
- Forensic investigation
Explore Further
Design Verification
- QMS ISO 13485:2016
- Testing capability
- Metrology (what is made?)
- Non-Destructive testing (meets specification?)
- Destructive testing (how robust is it?)
Explore Further

What UPC Offer

22 years of innovation, data & analysis creating wealth and IPR. Our services are:
Double Click Button

Product Consultancy
-Business Start-up services
-Patent support
-Managing innovation
-New Product Development
-Device services
-Regulatory Approval
-Product Industrialisation
Explore Further
Engineering Consultancy
- 1st principles Engineering
- New Product Development
- Drug delivery systems
- Sustainable life-cycle
- Root cause investigations
- Forensic investigation
- Testing and analysis
- Quality Strategy
Explore Further
New Product Development
- Project planning
- IP generation
- RMP, FTA, FMEA u,d&p
- Quality Strategy
- POP Models & Prototypes
- Predictive Modelling
- Design verification
- Approvals CE, CA, MDD, CFR
- Product Industrialisation
Explore Further
Drug Delivery Systems
- Medicines - treatment options
- Nasal Spray PDC
- Injectables & Inhalers
- Pumps - Patch & Syringe
- Disease Monitoring
- Regulatory approvals MDD
Explore Further
Sustainable Life Cycle Products
- Global warming potential
- Climate change
- Carbon life-cycle analysis
- Light-weight design
- Lower carbon emissions
Explore Further
Root Cause Analysis
- Novel design-led method
- FTA, FMEA
- Testing and analysis
- Predictive modelling
- Industrialisation review
- Quality Strategy
Explore Further
Ultra-Reliability QMS
- Experience derived QMS
- Ultra-reliable device method
- Embedded FTA, FMEA @ start
- Quality Strategy throughout
- Patient safety champion
Explore Further
Predictive Modelling
- UPC unique 6σ approach
- CTQ driven method
- Dimensional class by CTQ
- Function block models
- Stepping models - time, etc.
- Physics & Verification models
Explore Further
Forensic Witness
- Accident reconstruction
- Dispute resolution
- Patent, Trademark
- Civil versus Criminal
- Forensic investigation
Explore Further
Design Verification
- QMS ISO 13485:2016
- Testing capability
- Metrology (what is made?)
- Non-Destructive testing (meets specification?)
- Destructive testing (how robust is it?)
Explore Further

Medical Fields of Interest

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Diabetes
Explore Further
Rheumatoid Arthritis
Explore Further
Covid-19
Explore Further
Asthma
Explore Further
Mental Health
Explore Further
Heart Disease
Explore Further
Digestive Health
Explore Further
Cancer
Explore Further
Dementia
Explore Further
Blog
Explore Further

Medical Fields of Interest

Double Click Button

Diabetes
Explore Further
Rheumatoid Arthritis
Explore Further
Covid-19
Explore Further
Asthma
Explore Further
Mental Health
Explore Further
Heart Disease
Explore Further
Digestive Health
Explore Further
Cancer
Explore Further
Dementia
Explore Further
Blog
Explore Further

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We start with the end in mind. Safety and efficacy in manufacture.  FTA, FMEA’s , Modelling, Quality combined.