Services

SmartPath interdisciplinary team with extensive experience in medical device development and commercialization alongside a diverse skill set allows us to cater to a wide range of needs within the medical device industry.

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Business Consulting for Investors

R&D Support for Medical Device Companies

Services for Dental Companies

eQMS System Implementation

Business Consulting for Investors

The Journey of medical devices from development to reaching patients involves navigating numerous regulatory requirements. It’s essential to have specialists onboard to ensure a timely and cost-efficient development process. We can step in as your R&D/RA subject matter experts during the due diligence phase, providing you with valuable insights and recommendations for your future investments.

If your current investment faces development challenges, regulatory hurdles or becomes stuck, we are equipped to rescue your investment.

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We rescue your medical device investments

Medical device development process:

R&D Support for
Medical Device
Companies

No matter what critical competencies you may be missing in your development team or if you are considering outsourcing certain aspects of your medical device development, we are here to offer you comprehensive support across a range of tasks. From tailored development plans to conducting specific assessments throughout the development process including manufacturing scale-up and process improvements. We have you covered!

Our approach involves assembling an expert team that is specifically customized to meet the unique needs of your project. This ensures that you receive the precise expertise and skills required to drive your medical device development forward effectively.

We offer comprehensive support throughout the entire development process by providing assessments for each step.

Proof of principal assessments
Design input/requirement checks
Proof of concept assessments
Design transfer/industrialization checks
Biological evaluations
Validation package including clinical evidence package
Single document reviews

You want to accelerate your medical device development and don’t know how to move further.

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We rescue your development

Kickstart Service

Our services also include support for early-stage startups to identify the best path to succeed.

Help you with prototyping and integration of clinical expert feedback into your design
Clarification if your idea is patentable and how to write a patent
Preliminary development and manufacturability assessments
Market assessment
Preliminary regulatory affairs assessment
Development project plan
Support to draw up a business plan

Rescue Services

We provide three consecutive services aimed at rescuing your investment or development. We offer the flexibility to book these services together or step by step, based on your specific needs. We ensure that you receive both a concise one-page summary and comprehensive documentation.

Our rescue services begin with an honest reality check, followed by a thorough gap analysis and action plan. This will be your roadmap to success, and we can offer you the necessary support to execute it effective.

Reality Check

Overall risk indicator
Assessment of RA/QA pathway
Showing the R&D status
Assessment of the market
Assessment of costs and margin
Assessment of project timelines
Recommendation how to proceed

Gap Analysis

Overall back on track indicator
List of found gaps in RA/QA pathway
List of found gaps in R&D
Financial gaps in costs and margin
Updated timelines
Recommendation how to proceed including action plan

Project Tracking

Follow up on action plan
Are costs, resources and timelines still on track?

Services for Dental Companies

Leveraging our extensive work experience and deep understanding within the dental industries alongside current development trends, particularly in response to the clinical need for improved tissue integration. We are well-positioned to offer solutions that align with these market trends.

In addition to our development assessment for medical devices, we support you in the following areas.

Screening technologies to upgrade your implants and abutment on:

Development path
Manufacturing and Scale-up
Clinical and Biological Benefits
Regulatory Pathway (e.g., Europe, USA & APAC)

Defining your go-to-market strategy
Your scientific product positioning & claim substantiation plan
Pre-clinical study design for registrations

eQMS System Implementation

We specialize in the seamless integration of robust and efficient quality management processes within your organization. Our dedicated team ensures the systematic development, implementation, and continual improvement of your QMS, aligning it meticulously with regulatory standards and industry best practices. With our expertise, we facilitate a streamlined and compliant QMS tailored to your specific needs, fostering operational excellence, and ensuring the highest quality standards for your products or services.

Services

Business Consulting for Investors

R&D Support for Medical Device Companies

Kickstart Service

Rescue Services

Reality Check

Gap Analysis

Project Tracking

Services for Dental Companies

eQMS System Implementation

Collaborations

R&D Support for
Medical Device
Companies