Startup Medical Device Companies
Joining the medical device industry is an exciting endeavor, yet there are significant considerations, processes, and protocols for entrance. You may find yourself questioning decisions or not understanding the complex regulations, yet these initial steps for entrance are critical in order to establish your business as a sustainable competitor.
Fang Consulting offers the staff augmentation services and consulting your company needs to build a dependable product that will initiate your company with purpose and reliability. From regulatory management to quality consulting, Fang Consulting’s remote consulting services extend direct assistance to medical device startup companies.
We can guide and educate startups on each step of the regulatory submissions process so you can be confident your business is abiding all regulatory demands. See below for our medical device regulatory consulting services that are specific to the needs of startup companies.
- Regulatory strategy
- Global regulatory compliance and registration support
- FDA and other regulatory authority meetings
- FDA pre-submission meeting guidance
- Technical file development
- Person Responsible for Regulatory Compliance (EU MDR Article 15)
Ensuring your company starts with a solid foundation means constructing an established quality management system (QMS) to confirm all products are manufactured correctly and all global regulatory compliance requirements are met. The Fang’s consulting staff will assist with the development of your QMS system to guarantee all requirements are accounted for to negate possible product deficiencies and recalls.
- Quality management system (QMS) development
- Electronic Medical Device Reporting (eMDR) & EU Vigilance Reporting
- Third party ISO 13485 audits
- EU MDR strategic gap analysis
- ISO 13485 strategic gap analysis