MEDTech | Consultant-Medical Device Consultancy

Example

Assisting in implementing and maintaining a QMS compliant with ISO 13485, crucial for manufacturers to demonstrate compliance to regulatory requirements.

Scenario

A medical device startup planning to enter the European market requires assistance in setting up a QMS that meets the European Union Medical Device Regulation (EU MDR) requirements.

Example

Providing strategies for navigating complex regulatory landscapes, including FDA submissions and CE marking processes.

Scenario

A company developing a new diagnostic device seeks guidance on regulatory submission strategy for FDA approval, including preparing the necessary documentation and responding to regulatory queries.

Example

Offering expertise on the product development process, focusing on design controls, risk management, and user requirements to ensure the device is designed with safety, efficacy, and regulatory compliance in mind.

Scenario

Guiding a team through the design control process for a novel wearable health monitor, ensuring all steps from design inputs to verification and validation are properly documented and meet ISO 14971 risk management requirements.

Example

Advising on market entry strategies, including identifying target markets, competitive analysis, and commercialization strategies.

Scenario

Supporting a biotech firm in developing a market entry strategy for their new blood glucose monitoring system, including analysis of target demographics, competitive landscape, and potential partnership opportunities.