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.