The Consultancy services offered by SHIL include:
- Implementation of and monitoring quality assurance systems to ensure compliance with BS EN ISO 13485 for medical devices.
- Clinical development plans, management of clinical trial supplies and clinical monitoring
- Preparation and monitoring of project plans to develop medical devices from inception through to regulatory submission and launch
- Regulatory strategies for product licensing and approval, US and Europe
- Liaison with regulatory agencies
- Transfer and validation of processes from development to production
Examples of recent projects are listed below:
- Contract providing weekly on-site quality management services to maintain CE certifications, Host Notified Body audit, Maintenance of Technical Files and Design Dossiers and submission of change notifications.
- Performed audit, gap analysis and action plan for companies.
- Review feasibility of seeking quality accreditations and provide recommendations for a healthcare company.
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