Our Projects
The experience we have been gathering in the MedTech Industry since 2010 is embodied as PMforMedTech. So far we have completed a variety of projects in the Industry, each of which increased our confidence to contribute more and to do better! Below is a some examples about our capabilities.
01
Project Scope: Quality Engineering Management
Project Definition:
Leading all quality activities for a technology transfer project.
01
Quality Engineering Management
This multiyear, multisite project aimed to transfer and make fully validated, semi automated production process line. Included process and computer systems validation for the automated part and included CAPEX and full process validation for the non-automated site. Our role was to manage all the quality engineering activities for this project. This included risk management according to ISO14971, reviewing and approving all process validation documentation (including CSV), any deviations in the system (NC's and CAPA's), guiding/training engineering team, playing a critical role in site transfer activities, and enrolling in all the deviations and trouble shooting activities.
02
Product Industrialisation
Production Line transfer from Germany to the Netherlands. We engaged after the physical transfer was completed. Preparing the line for serial manufacturing included the following activities: Validation of entire manufacturing line, updating SAP to make sure the line and the related upgrade kits are added properly, ensuring all supplier related aspects are closed, creating / updating WI's & SOP's for the entire process, training of the related personnel, getting approval from the Management Team (MT) for the release of the production process for serial manufacturing.
03
QMS Integration
After acquisition of a smaller company, the client did not want to pursue two different QMS's and wanted to integrate them. Within scope of this activity, we updated the roles and responsibilities of the personnel, assigned procedures according to their training needs, added all the machinery and equipment into the main site's tracking system, completed the related maintenance and calibration gaps and initiated EHS activities for complete integration.
04
Transition to EU MDR 2017/745
This project started in 2018, one year after the EU MDR came into affect. During this project we prepared one of the first EU MDR compliant Design Dossier which then is used as exemplary file by a leading notified body in their designation. By using this as a benchmark, we assessed and updated several NPI project technical documentation to bring them into EU MDR compliant level. In total, we worked on 20+ NPI projects at different phases, ranging from Medical Electric Equipments (MEE) to Software as Medical Devices (SaMD)
05
Lab Equipment Validation
During this short term project, we worked with engineers and lab technicians to ensure the purchased but not validated equipment are put in use. Some required full GxP compliancy, including a Validation Plan, Risk Assessment, URS, Compliancy Analysis, Test Method Validation, Work Instruction update and reporting out. This task also included supplier management activities, like selection of new suppliers or adding suppliers into ASL (Approved Supplier List)
06
PTC Windchill SW update
To make the in-use software EU MDR 2017/745 compliant, we worked with a project team to assess and update the gaps. SW validation followed GAMP 5 approach.
07
UDI Implementation
This project oversees leading the work package to review and update the product portfolio of the products manufactured in 5 locations (USA, India, The Netherlands) to ensure the portfolio contains EU MDR compliant Unique Device Identifiers (UDI) in their labelling. Also in scope was to create database for EUDAMED registration of these products
08
Technology Transfer / Process Validation
Project scopes, transferring the know-how of manufacturing of a Medical Device to a new location and ensuring that all the process validation activities are performed at this new location. Performed activities involved, performing IQ, OQ, PQ of the equipment, packaging & transport validation, cleaning validation, creating / updating WI and related SOPs, training of the employee.
09
NPI Project Management
Project Management of a few implantable cardiovascular(PDA, ASD, PFO) medical devices including one that was unique on the market (PLD). Work package included, following up completing all product validation activities including the biocompatibility testing according to ISO 10993, animal studies where applicable, clinical studies and preparation and submission of the technical documentation for CE marking. Worked with the world known Key Opinion Leaders (KOL) in their fields to successfully continue and finalise clinical trials.
10
ISO 13485 QMS Implementation
Project involved contributing to the creation of Quality Management System (QMS) according to ISO 13485. Starting from mission and vision and then creation of the org chart, together with a team of experts we created the entire QMS and prepared the site for a notified body audit.