Medical Devices

Design and development of solutions for minimally invasive surgery including laparoscopic instruments,and access ports

Remediating 50+ Technical Files to new EU Medical Device Regulations and maintain essential ICU products on market duing Covid pandemic

Supporting specialist wound care projects with Design History documents including translations and  international  production processing sites

Technical and regulatory consulting for catheter products, including labelling and translations to maintain products on market

State Of Art standards review and pre-audit of medical device documentaion in preparation for critical Notified Body CE certification visit

Managing EU, UK and US cross-border teams to create robust engineering, production quality, and regulatory DHF content with peer review

Design and development of Class III implants plus Technical Files  for audit and CE market clearance

Evolution of product portfolio, manufacturing optimisation with complete project management

From concept sketch to volume production: full Design History File plus innovative features  

Application of novel polymer material technologies from R&D laboratory to commercial launch

Combined new materials with unique product geometries through to successful clinical trials

Manufacturing analysis and CAPA for Class III injection moulded Autologous transfusions bottles

Developing implants with bioactive materials such as hydroxyapatite coating to improve bone bonding

High quality prescision machining technologies and  finishes  including  milling, turning and polishing

Development engineering  of implants with porous plasma spray for fixation and bony in-growth

Development engineering for metered-dose inhaler project to investigate and resolve mechanical design issues and coordinate laboratory testing

Design History File review, audit and documentation creation for drainage and waste collection systems including full Risk Management

From clinician led design projects to redesigns Complaints` CAPA root cause analysis, production process improvement 

 Custom medical chairs development including IP patents for headrest designs, and critical global supply chain management

Production optimisation and design improvements for a range of hospital apparatus including key hole surgery and  operating theatre equipment 

Development of implants and their surgical techniques inclduing pre-operative planning devices; xray templates, trials and guides

Compliance engineering for disruptive innovation led projects incorporating  active wearable technologies

Navigating complex regulatory landscapes for borderline sport medicine and wellness products including IVD

Technical project consulting for regenerative medicine, and intimate health applications including  femtech

Project Management of NPD, engineering clinical Transcranial Magnetic Stimulator products

 Engineering development of stand alone medical software products including international usability studies

Supportiing powered devices that enable movement for pateints with neurological or neuromuscular conditions 

Designing instrumentation incorporating electrocautery and surgical diathermy for EU and US markets including support for FDA 510(k)

Project management of international production line transfer and cartridge manufacturing quality engineering for scale up

Medical devices with software and touch screen based user interfaces; design development, usability studies and validation