You need a team of focused quality and regulatory professionals, uniquely prepared for tackling today’s medical device company projects. We assemble “plug and play” teams that provide the exact skillsets you need to round out your staff.
Synergy is a beautiful thing.
Whether you’re looking to obtain ISO 13485/9001 certification or wanting to ensure compliance to 21 CFR 820, Medgineering™ provides the systems, document templates, high level strategy and streamlined roll-out that are important.
Medgineering™ and partners are experts in building a company’s Quality Management System (QMS) from scratch.
Remediation is project-based “fixing” of company practices & procedures, products or strategic focus.
Remediation projects are unique in that they require individuals with knowledge bases different than traditional engineers; these specialists must be up to date on best practices, FDA Warning Letter and 483 observations and solutions and common industry practice mistakes. Furthermore, remediation methodology is a fast-paced, high impact strategy that requires quick integration into a company’s operating and quality framework without compromising time or money.
All of our projects begin with a thorough gap analysis and scope analysis to ensure accurate forecasting of budget and timelines.