Consultancy and support for Medical and Pharma Device Services
PS Partnerships provide clients with unique range of resources and skills to support and develop and manage their pharma and medical devices.
We have a multi-disciplinary team
PS Partnerships provide a unique range of services to Medical and Pharma industries and their supply chain. This includes product development, achieving regulatory compliance, managing change, understanding risk, and implementing medical quality management systems.
Specialisms include drug delivery, orthotics, and continence products
Our projects in the medical and pharma device sectors include:
- Material selection and design guidance
- Implementation of quality management systems such as ISO 13485
- Regulatory compliance support and consultancy
- Supply chain development and de-risking
- Product failure analysis
- Drug contact and biocompatibility studies
- ISO 14971 risk management support and training
- Reducing device environmental impact
- Polymer training for organisations in the medical and pharmaceutical supply chain
How we can help with medical and pharma devices
Material Selection, Material Specification Development, Procurement and Supply Chain Support, Process selection for Manufacture.
Preparation of Device Technical Files, EU MDR and UK MDR 2002 Preparation, Gap Analysis and Audit Preparation.
Implementation of ISO13485:2016, Preparation of Procedures and Processes, Gap Analysis and Audit Preparation, ISO14971:2019 Risk Management Support and Training.
Polymer Device Failure, Plastics Processing and Product Manufacturing Faults, Intellectual Property Evaluation, Product Compliance Appraisals, Product Technical Due Diligence.
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