7TP CONSULTANCY
7TP Consultancy provides technical expertise and project management services to the medical devices / combination products and pharmaceuticals industry, with Quality at the heart of everything we do.
TECHNICAL SERVICES
Design Engineering
Design for Manufacture / Assembly
Drug Delivery Devices / Pen Injectors/ Auto-Injectors / On-Body Delivery Systems (ISO 11608)
Human Factors Engineering (IEC 62366)
Medical Electrical Equipment (IEC 60601)
Shipping Validation (ASTM D4169-16)
Research & Development
Process Validation
Root Cause Investigations
Technical Due Diligence
QUALITY & REGULATORY
Risk Management (ISO 14971), FMEA, FTA, PHA
Design Controls & QMS (ISO 13485, 21 CFR 820.30)
Combination Products (21 CFR Part 4)
DHF/ Technical File Management
Project Management
Software Life Cycle (IEC 62304)
Support for CE-marking (MDR)
Support for BLA/NDA/ANDA combination product submissions
PEOPLE
Steven: Principal Consultant & Chartered Engineer
Steven has developed his skills and experience in the medical devices and combination products field, with over a decade of experience in the design consultancy, Device OEM and bio-pharmaceutical/ combination product industries. With a background in Mechanical Engineering and as a Chartered Engineer (MIMechE), Steven provides both project management and technical leadership of medical device programmes with Quality and Integrity at the forefront of everything he does, whilst maintaining a keen interest in technologies and technical development.
