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)
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 15 years 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.
