Secure BioMed Evaluations
is a strong partner for your
med tech company!
Secure BioMed Evaluations is a group of talented engineers and project managers that know how to test, streamline and troubleshoot. We stay at the leading edge of the biomaterials and devices that enhance the life of patients.
"Our goal is to get your medical device to market faster. We know we have done our job when you are selling a product and no longer need SBME…"
- Linda Greer Braddon, Ph.D.
Team Skills
Medical Device Engineers:
Our medical device engineers have a track record of bringing devices to market via PMA, 510(k), and CE marking paths. Each team member has real world experience in product development, R&D support, mechanical testing and design, implementation of design controls, technical writing including literature reviews, clinical protocols, regulatory submissions, engineering documentation, labeling, and IFUs.
Quality Systems Implementation:
Secure BioMed Evaluations quality control and systems staff have extensive experience in installation and implementation of quality system regulations including 21 CFR Part 820 including GLP, ISO 13485, MDD, and CMDCAS. Members of the quality control team have been responsible for quality engineering, inspection and testing, product failure analysis, and documentation control and configuration management. The SBME team has real world experience in instituting quality systems that resulted in successive ISO registrations: the initial assessment to 9001:1994, with upgrades to 9001:2000 and 13485:2003. Additionally, quality team members have experience performing regulatory audits of vendors and gap analysis of quality systems for start-up medical device companies.
Medical Advisory Team:
Secure BioMed Evaluations has strategic alliances with medical leaders in various areas including orthopaedic, cardiovascular, emergency medicine, and urology. These specialized and talent medical doctor advisors allow our engineers and quality teams to get a clinical viewpoint on demand. The insight of these medical doctors is just one of the key advantages SBME brings to its clients.
Project Management:
To make sure all projects run both on time and on budged, every project is assigned a manager. " My job is to streamline the process for the SBME clientele in managing the integration of teams and resources in a smooth and seamless operation. We understand that a medical device company needs a product to be profitable and we help our clients bring their products to market faster!"