Regulatory strategy and regulatory planning are an essential part of establishing a medical device or life science company. The regulatory strategy is an integral part of the overall company business plan and later, of every development project.
HaMaDa will work together with you to build a strategy that fits your technology, business objectives, target market and complies with specific regulatory requirements.
Medical regulatory requirements are complex. The team at HaMaDa provides global regulatory consulting for Medical Device and IVD companies. We deliver innovative ideas, top-notch capabilities and extensive global regulatory affairs knowledge to help you bring products to markets in the USA, Europe, Israel and the Rest of the World (RoW).
HaMaDa provides highly professional on-going support as well as mentoring to your company’s in-house regulatory team.
Services available include:
- Establishing a regulatory strategy
- Review of current regulatory strategy
- Medical Device product classification and submission strategy
- EU Technical File or Design Dossier Compilation to obtain CE Marking Approval
- Preparation of a clinical evaluation report
- MDD 93/42/EEC Essential Requirements Preparation
- FDA Pre-Investigational Device Exemption (Pre-IDE) consulting
- Participate in meetings with the FDA
- FDA 510(k) submissions for obtaining FDA approval (clearance)
- US Premarket Approval (PMA) consulting services
- FDA De Novo submission support for Medical Device companies
- Preparation and submission of regulatory applications for ROW i.e. Israel, Canada (list of countries available upon request)
- Investigation and reporting of incidents and adverse events
- Support on corrections and removals
- FDA Form 483 and Warning Letter Analysis, response and recovery
- Medical Device registration
- Obtaining Certificate of Free Sale
- Deciding on when to submit product changes and Writing Letters to the File
- Regulatory review of Labeling and User Manuals
- Annual updating of the clinical evaluation report
- Providing Regulatory input at ECB meetings And more
