Project management in the medical device and biotechnology industry is essentially management of various disciplines to achieve one goal; to bring your product to the market within the budgeted project costs, with the available resources and within the agreed time frame while guaranteeing the product quality and safety.
Depending on the project size and description, project management can involve the management of a team of experts from e.g. Marketing & Sales, Business Development, Research & Development, Regulatory Affairs, Production, Clinical and Quality Assurance.
MDProject has experienced project managers who can manage your entire project, regardless whether the project involves the complete Product Development Cycle or when the project is a subproject or a design change.
Since we have our background in the medical scientific area we are not only capable of managing your project with regard to:
– Preparation of project plans
– Regulatory and quality compliance
but we can also act a team member and support and advise in the vertical field of the project with regard to:
– Packaging and labeling
– Shelf life
Full Project Management
For several clients we currently act (and have acted) as a project manager in projects that start with a research idea and end up with a marketable finished device. Playing that role, we coordinate and manage a team of experts and focus on project planning and meeting agreed timelines within the available budget and with the available resources. We motivate the involved people in order to create a communication platform for running a smooth project and keeping the stakeholders up to date. We make sure that the deliverables are properly documented and filed in a pre-defined file structure, which is suitable for regulatory submissions or project divestments.
By creating a clear project structure and acting as a facilitator we are able to perform the management coordination of your entire project and relieve your organization.
We have acted as project manager for the development of a high risk:
– degradable polymer bone implant serving a bone cement stopper
– degradable polymer bone void filler
– degradable animal derived hemostat
– degradable polymer dermal filler
Project Team Member
Project Team Member
Having extensive in dept knowledge, we can also act as a team member for specific subprojects in your project. We are capable of managing and/or actively participating in subprojects that handle topics like e.g. biocompatibility safety evaluation, packaging validation and labeling, sterilization validation, shelf-life validation and (clinical) risk assessments according to ISO 14971.
Our biocompatibility expert is also consulted as expert reviewer by a notified body.
We make sure that deliverables are met and that evidence is gained according to the applicable standards and guidelines.
Because we all have a university R&D background, we are capable of writing technical and scientific reports that meet the regulatory requirements.
We have acted as a team member in the following subprojects:
– Biocompatibility safety evaluation of high risk degradable wound dressings, IUD’s, cardiovascular stents, balloon catheters and guide wires, degradable hemostats, orthopedic implants, etc.
– Production, packaging and shelf-life validation of a high risk degradable wound dressings, degradable animal derived hemostats, dental implants, etc.
– Gamma irradiation sterilization validation of wound dressings, hemostats, implants
– Validation of an aseptic filling processes
– Product and process risk assessments of high risk products like, bone/cartilage/soft tissue implants, animal derived hemostats, wound dressings, dental implants, etc.