iDE8 Ltd
Medical Device Consultancy, operating under iDE8 Ltd, specializes in supporting medical device companies through all stages of product development, quality assurance, regulatory compliance, and post-market support. With a mission to accelerate the development and market entry of medical devices, they offer bespoke solutions tailored to each client's needs, ensuring products are safe, effective, and compliant. The company emphasizes innovation, transparency, timeliness, and building trust with clients, stakeholders, and regulatory bodies.
Industries
Nr. of Employees
small (1-50)
Services
End-to-end clinical data services including EDC implementation, data cleaning, CDISC dataset creation, and statistical analysis for regulatory submissions.
Design and operation of quality management functions including QMS implementation, document control, CAPA management and e-QMS administration.
Software V&V, computer system validation, cloud validation and supplier audits to ensure software and systems meet regulatory requirements.
Regulatory strategy, pre-market submission support, local representation and management of registrations and communications with competent authorities.
Feasibility studies, device characterisation, mechanical and electrical testing, software testing, V&V and lot/batch release testing with reporting for regulatory submission.
End-to-end product development services including requirements engineering, technical leadership, V&V management and multi-source design coordination.
End-to-end clinical data services including EDC implementation, data cleaning, CDISC dataset creation, and statistical analysis for regulatory submissions.
Design and operation of quality management functions including QMS implementation, document control, CAPA management and e-QMS administration.
Software V&V, computer system validation, cloud validation and supplier audits to ensure software and systems meet regulatory requirements.
Regulatory strategy, pre-market submission support, local representation and management of registrations and communications with competent authorities.
Feasibility studies, device characterisation, mechanical and electrical testing, software testing, V&V and lot/batch release testing with reporting for regulatory submission.
End-to-end product development services including requirements engineering, technical leadership, V&V management and multi-source design coordination.
Expertise Areas
- Clinical trial management
- Biostatistics and data analytics
- Clinical data management and CDISC
- Quality management system design (ISO 13485)
Key Technologies
- Electronic data capture (EDC)
- CDISC SDTM/ADaM standards
- Statistical software (SAS, R, Stata)
- e-QMS and computer system validation (CSV)
News & Updates
Recognition for innovation in medical device consultancy services.
Recognition as a leading medical device consultancy.
UKAS AND ISO 13485 CERTIFIED
Certification indicating compliance with international quality standards.
Award recognizing innovative contributions in the medical device field.
Recognition as a top medical device consultancy.
Recognition for innovation in medical device consultancy services.
Recognition as a leading medical device consultancy.
UKAS AND ISO 13485 CERTIFIED
Certification indicating compliance with international quality standards.
Award recognizing innovative contributions in the medical device field.
Recognition as a top medical device consultancy.