Engineering services for medical devices, combination products, and safety-critical systems: Design, analysis, and risk management
International Device Solutions Ltd
Manchester (Prestwich), GBNew on Amplifa
About International Device Solutions
International Device Solutions Ltd (IDS) is a people-week British engineering consultancy established in 2014, based in Prestwich, Manchester (UK), specializing in medical devices, combination products, and safety-critical systems. The company supports pharmaceutical and medical technology manufacturers with device and process design, in-depth analysis of existing products, IP generation, troubleshooting and root-cause analysis in manufacturing, and due diligence for M&A projects. Services include risk management according to ISO 14971 (PHA, design, process, and user risks), Quality Systems according to 21 CFR 820, EU MDD, and ISO 13485, DFM/DFA analyses, pilot/rapid tooling for clinical supply, as well as transition and scale-up according to Quality by Design. IDS creates technical and regulatory documentation, evaluates and trains suppliers, and provides on-site support and oversight regardless of location. The founder and Technical Director is EurIng Neil Bentley Cammish, Chartered UK Engineer and Fellow of the Institute of Engineering Designers. Clients include F. Hoffmann-La Roche.
- Site
- M25 1EJ Prestwich, Manchester
- Processes
- Device design and analysis (3D and 2D design outputs), Design for Manufacturing and Assembly analysis / manufacturing method design and planning, Pilot or rapid tooling and manufacturing for clinical supply / transition and scale up, Risk management systems (ISO14971), Quality systems review / design controls (21CFR820, EU MDD, ISO13485), Supplier evaluation, management and on-site oversight, Device and Process Design (Injection/Respiratory Devices, Combination Products), Deep-Dive Review and Analysis
- Materials
- Risk Management, Quality Systems, Medical Device Quality Management, Quality by Design
- Certificates
- ISO 13485 (Competence/Application), ISO 14971 (Risk Management), 21 CFR 820 Design Controls, EU MDD
- Founded
- 2014
- Employees
- 1-10
- Industries
- Medical Devices, Pharmaceutical Industry / Drug Delivery, Combination Products, Safety-critical Systems
- 01
Requirements Analysis (User Needs / URS / Design Inputs)
- 02
Device and Process Design (3D/2D)
- 03
DFM/DFA Analysis and Manufacturing Method Planning
- 04
Risk Management according to ISO 14971
- 05
Pilot/Rapid Tooling and Manufacturing for Clinical Supply
- 06
Oversight, Supplier Management, and Scale-up
- 07
Technical and Regulatory Documentation
Services and Standards
Risk Management
Creation and maintenance of risk management systems in accordance with ISO 14971 and EU/US regulations, linked to Design Inputs and Outputs.
Quality Systems
Review of existing systems for compliance with Design Controls according to 21 CFR 820, EU MDD, and ISO 13485.
Medical Device Quality Management
Compliance check and integration of Design Controls into existing QM systems.
Quality by Design
Linking manufacturing control with quality attributes and associated risks during scale-up.
Location
Manchester (Prestwich)
GBRegistered Office / Administration
Project Examples
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Device design and analysis (3D and 2D design outputs)Engineering | – | – | – | – | – |
| Design for Manufacturing and Assembly analysis / manufacturing method design and planningEngineering | – | – | – | – | – |
| Pilot or rapid tooling and manufacturing for clinical supply / transition and scale upEngineering | – | – | – | – | – |
| Risk management systems (ISO14971)Engineering | – | – | – | – | – |
| Quality systems review / design controls (21CFR820, EU MDD, ISO13485)Audit | – | – | – | – | – |
| Supplier evaluation, management and on-site oversightAssembly | – | – | – | – | – |
Additional services
Reference customers
Quality and Compliance
IDS creates and maintains risk management systems according to ISO 14971 and checks QM systems for compliance with Design Controls according to 21 CFR 820, EU MDD, and ISO 13485, including Design Verification, Validation, and Biocompatibility Reports.
| Evidence | Manchester (Prestwich) |
|---|---|
| ISO 13485 (Competence/Application) | |
| ISO 14971 (Risk Management) | |
| 21 CFR 820 Design Controls | |
| EU MDD |
History
- 2014
Founding of International Device Solutions Ltd by Neil B. Cammish (Companies House 09090918, Year derived from database, low evidence trust)