The Jans Group, LLC
Defining the regulatory pathway to deliver positive results
What We Do
Discover our medical device regulatory expertise
US Regulatory
The needs of each company are unique and require consulting resources that are knowledgeable, experienced, flexible, and adaptable. Here are some examples of regulatory services that The Jans Group can provide: authoring and submitting 510(k)s, PMAs, pre-submissions, and IDEs, corresponding with FDA, preparing regulatory strategy and plans, performing regulatory assessments of changes, biocompatibility assessments, designing and managing reprocessing and sterilization studies, labeling development, authoring IFUs, Advertising and Promotion (A&P) review. We can also support other regulatory and quality responsibilities such as Medical Device Reporting and field corrections and removals, FDA establishment registration and listing, authoring SOPs, creating templates, and conducting training.
EU Regulatory
The Jans Group has extensive experience with CE marking, technical file or design dossier development, and working with Notified Bodies. Here are some examples of the services that we can provide: authoring and submitting MDR / MDD technical documentation and clinical evaluations (CERs), preparing CE Marking strategy and plans, corresponding with Notified Bodies, IEC 60601 support, compliance standards assessment, EU labeling development and IFUs, Medical Device Vigilance reporting, and Field Safety Corrective Actions support.
International Regulatory
The Jans Group has a deep knowledge of global regulatory environments and submission requirements. With excellent communication and negotiation skills, product approval experience has been obtained in many international countries such as: Australia, Brazil, Canada, China, Korea, Indonesia, Japan, Mexico, Saudi Arabia, Singapore, Russia, Taiwan, and Turkey.
About Us
The Jans Group, LLC was founded in 2019 by Michele Jans after 20 years in medical device quality and regulatory leadership roles for large and small medical device companies, including startups. She is a highly-skilled, committed, and solutions-driven Regulatory Professional with a track record of successful submissions in the US, EU, and internationally for medical devices and IVDs. Michele has a deep knowledge of global regulatory environments, superlative analytical and negotiating skills, and effective management of human and capital resources.
Michele has driven multiple successful pre-marketing authorizations (PMA, 510(k), CE Mark) and regulatory projects. She has excellent organizational, planning, budgeting, and technical writing skills.
Get In Touch
Contact us and find out how our expertise can benefit your company.