Startup Services

Supporting Startups to Navigate the Journey from Idea to Market

Bioexcel Medical Device Research Organisation offer

Startup Services: Empowering Medical Device Innovators

At Bioexcel, we understand the unique challenges faced by medical device startups. From developing innovative ideas to navigating complex regulatory pathways, our tailored services are designed to empower startups to achieve success in a highly regulated industry. With a focus on compliance, quality, and market readiness, we provide end-to-end solutions to help you bring your product to life.

Why Choose Bioexcel for Startup Support?

Medical device startups require a strong foundation in innovation, quality, and regulatory compliance to thrive in the competitive healthcare market. Bioexcel’s dedicated startup services are specifically designed to support innovators at every stage of their journey.

Key Benefits:

End-to-End Support: From concept validation to market entry.
Cost-Effective Solutions: Scalable services tailored for startups with limited resources.
Regulatory Expertise: Simplify complex regulatory pathways with expert guidance.
Accelerated Development: Streamlined processes to bring your product to market faster.

Our Startup Services

Regulatory Strategy and Device Classification

Navigate Regulatory Pathways with Confidence

We help you define a clear regulatory strategy and accurately classify your device to meet global compliance requirements.

Key Features:

Regulatory classification for FDA, EU MDR, CDSCO, and other regions.
Strategic planning for global market access.
Guidance on regulatory submissions and approvals.

Prototyping and Feasibility Studies

Turn Ideas into Validated Concepts

We assist startups in validating the technical and commercial feasibility of their ideas through prototyping and feasibility studies.

Key Features:

Prototype testing and usability evaluations.
Technical feasibility assessments.
Support for proof-of-concept studies.

Clinical Trial Support

Building Strong Clinical Evidence

We design and manage clinical trials tailored to your startup’s needs, ensuring compliance and robust data generation.

Key Features:

Clinical trial design and protocol development.
Investigator and site selection.
Data analysis and Clinical Study Report (CSR) preparation.

Quality Management System (QMS) Implementation

Establish a Foundation for Compliance

We help startups implement scalable QMS frameworks that align with ISO 13485 and FDA QSR requirements.

Key Features:

Design and implementation of QMS tailored to startup operations.
Internal audits and pre-certification support.
Documentation development, including SOPs and quality manuals.

Risk Management and Biocompatibility Testing

Proactively Address Potential Risks

We provide risk management and biocompatibility testing services to ensure the safety and performance of your device.

Key Features:

Preparation of Risk Management Files (RMF) as per ISO 14971.
Biocompatibility testing per ISO 10993 standards.
Hazard analysis and mitigation strategies.

Funding and Investor Support

Attract Investors with Strong Documentation

We help you prepare the technical and regulatory documentation needed to secure funding and investor confidence.

Key Features:

Clinical and technical data reports for investors.
Market research and business model validation.
Support for investor presentations and pitch decks.

Technology Transfer and Market Entry

Seamless Transition from Development to Commercialization

We support technology transfer processes and assist in launching your product in target markets.

Key Features:

Technology transfer planning and execution.
Distributor and partner identification.
Post-market surveillance and compliance support.

Case Studies

Challenge:

A startup developing a wearable device needed regulatory strategy guidance to access the US and EU markets.

Solution by Bioexcel:

Classified the device under FDA Class II and EU MDR Class IIa.
Developed regulatory submission plans for 510(k) and CE marking.
Prepared technical files and managed communications with Notified Bodies and the FDA.

Outcome:

Successfully obtained 510(k) clearance and CE marking within 12 months.

Challenge:

A diagnostic device startup required a scalable QMS for ISO 13485 certification.

Solution by Bioexcel:

Designed and implemented a customized QMS framework aligned with ISO 13485 standards.
Conducted internal audits and provided pre-certification training.
Developed SOPs, quality manuals, and risk management plans.

Outcome:

Achieved ISO 13485 certification within six months, enabling the startup to enter the EU market.

Challenge:

A SaMD startup required clinical evidence to validate their AI-powered diagnostic software.

Solution by Bioexcel:

Designed a clinical trial focusing on diagnostic accuracy and patient safety.
Managed trial sites, data collection, and statistical analysis.
Prepared Clinical Study Reports (CSR) for regulatory submission.

Outcome:

Provided clinical evidence that supported successful regulatory approval and market launch.

Why Startups Trust Bioexcel

Proven Expertise

Extensive experience supporting startups across medical device categories.

Scalable Solutions

Flexible services tailored to fit your resources and growth stage.

Regulatory Insight

Deep understanding of global regulations, including FDA, EU MDR, and CDSCO.

Innovation Focused

Dedicated to helping startups transform ideas into market-ready solutions.

Help & FAQ

Frequently Asked Questions

How early should I involve Bioexcel in my startup journey?

Ideally, we recommend partnering at the concept or feasibility stage to ensure your project is built on a strong scientific and regulatory foundation.

Can Bioexcel help with investor documentation?

Yes, we prepare detailed technical and regulatory reports to support your funding and investor presentations.

What if I’m targeting multiple markets?

Bioexcel specializes in global regulatory strategies, helping you navigate multiple regulatory frameworks seamlessly.

Partner with Bioexcel for Startup Success

Empower your startup with Bioexcel’s specialized services, ensuring a smooth journey from innovation to market entry. Let us help you bring your groundbreaking medical device to life.

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