At Symbiosis,
our team is your team!
Our Services
We integrate regulatory requirements into your company culture and management style, convert complicated regulatory concepts to simple actions, and facilitate cross-department communication.
We help your teams:
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Integrate the clinical needs to design requirements in the regulatory structure.
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Conduct the registration regulatory feasibility studies early in the D&D stage.
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Align the regulatory registration strategy with the business models and visions.
Strategy & Planning
Business & Regulations
Feasibility
We help your teams:
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Conduct the risk assessment with the cross-field teams.
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Integrate the resources and regulatory requirements into the design and development plan.
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Arrange early communication with the health authorities.
Design & Development
Medical Device
Regulatory Service
We help your teams:
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Complete medical device product registrations
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Analyze the gap between D&D work completion and records at different D&D stages during registration preparation
Registrations
USA
Taiwan
EU
We build and modify systems that:
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Comply with regulations, team dynamics, and company culture.
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Help your team become more efficient and focused on imperative tasks, instead of daily routine or documentation.
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Enhance quality, and risk management procedures to meet your company’s needs.
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Quality Management
System
ISO 13485
USA
Taiwan
WHO WE SERVE
Start-ups
Running a successful start-up is a delicate balancing act of maximizing limited finances while ensuring product quality and company growth.
We’re here to help you navigate the overwhelming world of regulations and avoid common industry pitfalls, all while staying comfortably within your budget.
Medium Enterprises
As a medium organization, you need to implement strategies to secure sufficient manpower, maintain a cost-efficient business model, and ensure flexibility in team structures to economize your time.
We break down extensive regulatory tasks into simple, accessible steps.
International Corporations
We understand your need to enhance departmental collaboration to ensure regulatory compliance across an expanding international market and wider diversity of clients.
We provide you with flexible, creative solutions to streamline your workflow to enhance cross-departmental cooperation.