MDTc
MDTc is a specialist consultancy for the medical device and healthcare industries, founded in 2002 near Cambridge. It offers comprehensive services to help companies navigate the complex route to market with innovative medical products, serving sectors such as Medical Devices, In Vitro Diagnostics, Drug Delivery Systems, Biotechnology, and Hospital Services. The company operates as small, effective teams of core consultants and specialists, providing expertise in regulatory strategy, quality systems, product development, and more.
Industries
Nr. of Employees
small (1-50)
MDTc
Bury Saint Edmunds, Suffolk, United Kingdom, Europe
Services
Consultancy for regulatory strategy, preparation of technical files and support for CE marking and US premarket submissions.
Implementation and remediation of QMS to meet ISO 13485 / ISO 9001 and FDA QSR requirements, including gap analysis, SOP development and staff training.
Process validation, software/computer systems validation including electronic records compliance, and sterile packaging validation services.
Project management for design and development of medical devices, including planning and coordination of design verification and validation.
Design support for clinical trials and preparation of device-related sections of clinical trial dossiers for multi-country studies.
Identification and assessment of contract manufacturers and manufacturing capabilities to support device production and scale-up.
Consultancy for regulatory strategy, preparation of technical files and support for CE marking and US premarket submissions.
Implementation and remediation of QMS to meet ISO 13485 / ISO 9001 and FDA QSR requirements, including gap analysis, SOP development and staff training.
Process validation, software/computer systems validation including electronic records compliance, and sterile packaging validation services.
Project management for design and development of medical devices, including planning and coordination of design verification and validation.
Design support for clinical trials and preparation of device-related sections of clinical trial dossiers for multi-country studies.
Identification and assessment of contract manufacturers and manufacturing capabilities to support device production and scale-up.
Expertise Areas
- Regulatory affairs for medical devices and in vitro diagnostics
- Quality management systems and ISO compliance
- Clinical trial design and clinical dossier preparation
- Product development and project management for medical devices
Key Technologies
- CE marking and conformity assessment
- US FDA 510(k) submissions
- ISO 13485 / ISO 9001 quality management systems
- FDA Quality System Regulation (21 CFR Part 820)
News & Updates
Revised Medical Devices Directive
Dr. Jed Place presents on the Revised Medical Devices Directive and launches compliance support programs.
MEDTEC UK Presentation
Dr. Jed Place presents on Product Launch and Post Launch Assessment at MEDTEC UK.
Coronary Catheter Assignment
MDTc appointed to develop regulatory and quality strategy for a coronary catheter start-up.
In Vitro Diagnostic Device Study
MDTc awarded regulatory strategy and market research assignment for a novel in vitro diagnostic device.
ISO 9000 Certification
Dr. Jed Place achieves ISO 9000:2001 certification for a pharmaceutical instrumentation manufacturer.
Manufacturing Partner Selection
MDTc leads the selection process for manufacturing partner for an electromechanical drug delivery device.
Revised Medical Devices Directive
Dr. Jed Place presents on the Revised Medical Devices Directive and launches compliance support programs.
MEDTEC UK Presentation
Dr. Jed Place presents on Product Launch and Post Launch Assessment at MEDTEC UK.
Coronary Catheter Assignment
MDTc appointed to develop regulatory and quality strategy for a coronary catheter start-up.
In Vitro Diagnostic Device Study
MDTc awarded regulatory strategy and market research assignment for a novel in vitro diagnostic device.
ISO 9000 Certification
Dr. Jed Place achieves ISO 9000:2001 certification for a pharmaceutical instrumentation manufacturer.
Manufacturing Partner Selection
MDTc leads the selection process for manufacturing partner for an electromechanical drug delivery device.