Drua Consulting provides comprehensive consulting services for FDA-regulated industry, especially catering to startups.

Providing expert consultation on generative AI startup operations, market research, intellectual property, proof of concept, risk management, and global regulatory clearances and approvals, Drua Consulting will tailor a plan that fits your strategic goals and operational scope.

Revolutionize Medical Diagnosis with Our Expert ML/AI Consultants

Explore the future of medical diagnosis with Drua. Our cutting-edge generative AI technology, in tandem with our team of expert ML/AI consultants, is poised to revolutionize the realm of medical devices. Imagine a world where diagnostic devices are powered by AI for earlier disease detection, more precise treatments, and enhanced healthcare provider support. Drua leads the way in this healthcare evolution, harnessing generative AI and being guided by our seasoned ML/AI consultants to develop innovative medical devices that improve diagnostic accuracy and patient outcomes. Join us in shaping a future where medical devices redefine healthcare. Collaborate with our dedicated consultants as we set new standards in medical diagnosis.

Book an appointment to chat with our clinical affairs consultant now.

Clinical Affairs

We are here to help you overcome the toughest regulatory barriers. Our Safe and Effective (SEC) approach to medical product FDA approval has worked for many of our clients, saving them time and money. Clinical validation of health products involves a rigorous process of evaluating the safety, effectiveness, and usability of these products in a clinical setting. This process is critical to ensuring that your products are reliable, accurate, and effective in improving patient outcomes. This process does not have to be expensive. We can help with:

1. Proof of Concept: The first step in clinical validation is to demonstrate that the digital health product has the potential to work as intended. This stage involves testing the product in a laboratory or simulated environment to evaluate its feasibility.

2. Preclinical Testing: Before a digital health product can be tested in humans, it must undergo preclinical testing to evaluate its safety and effectiveness. This stage may involve animal testing or other types of in vitro testing.

3. Clinical Trials: Clinical trials are the most critical stage of clinical validation. These trials involve testing the digital health product on human subjects to evaluate its safety, efficacy, and usability in a clinical setting. Clinical trials typically involve several phases, including small-scale pilot studies, larger-scale efficacy studies, and randomized controlled trials.

4. Regulatory Approval: Once a digital health product has successfully completed clinical trials, it may require regulatory approval before it can be marketed and sold to the public. The regulatory approval process varies depending on the country and the type of digital health product.

Overall, the clinical validation process is critical for ensuring that digital health products are safe, effective, and reliable tools for improving patient outcomes.

Book an appointment to chat with our clinical affairs consultant now.

Regulatory Affairs

With regulatory environments continually changing, clients depend on guidance from our experienced consultants to avoid costly mistakes, such as data omissions or deficiencies. Failure to comply with regulatory requirements can delay approval of new products or even trigger recalls, resulting in a substantial loss of revenue and/or reputational risk for the company.

Drua Consulting’s experienced consultants apply their up-to-date knowledge and expertise of regulations to help companies navigate changing regulatory environments. We provide support through all stages of the business or product lifecycle, such as defining regulatory pathways, identifying regulatory requirements, managing regulatory submissions, and assessing labeling and design changes.

We prepare regulatory strategies with submissions and registrations for:

• Q-Subs

• 513(g)

• De Novo Request

• 510(k)

• Premarket approval (PMA)

• Investigational Device Exemption (IDE)

• Technical Files and Design Dossiers

Book an appointment to chat with our regulatory consultant now.

Quality Assurance

Determining and meeting quality requirements are integral to ongoing regulatory compliance and smooth inspections and audits. Drua Consulting is fully trained and equipped to handle a range of quality work for our clients, from creating and implementing specific quality operating procedures to providing full, customized quality systems. We can also serve simply as experienced consultants and advisors on quality requirements. Our extensive experience in quality systems includes the following:.

Quality Management System (QMS) / Standard Operating Procedure (SOP) Development

We identify necessary procedures based on client and product-specific needs and develop and deploy customized standard operating procedures (SOPs).

Design Control

We provide design control solutions from concept through design transfer.  Our consultants guide our clients through the process of establishing and maintaining design history files (DHF).

Design Verification and Validation

Our consultants determine test requirements, select and manage appropriate laboratory service providers, generate protocols and reports, and advise on resolving failures.

Post Production Activities: 

Our consultant determines requirements and provides documentation and guidance on the following:.

• Nonconforming Material Reports

• Corrective and Preventive Actions (CAPA)

• Complaint Handling

• Medical Device Reporting (MDR)

• Health Hazard Evaluations (HHE)

• 483 and Warning Letter Responses

• Management Review

Risk Management

A risk management strategy is essential in the development and manufacturing of medical products; a rational and practicable risk plan must be integrated throughout the product lifecycle.  Drua Consulting develops solutions to address ISO 14971:2012 requirements for risk planning and risk management. We work with each client’s unique needs to generate a risk management strategy and plan that match both regulatory requirements and project scope.

Audits

Audits are often required for manufacturers and advisable for certain other types of companies. Internally conducted audits can provide necessary checks and balances on quality systems, confirm that suppliers meet expectations and standards, and prepare for external observers and third-party auditors. At Drua Consulting, our auditors are experienced in conducting internal and external audits; one of our consultants is a former FDA investigator. We provide independent and objective audits covering the following areas:

• Mock FDA and Notified Body Audits and Inspections (cGMP, QSR, and HACCP):

  • medical devices

  • foods

  • drugs

  • cosmetics

  • dietary supplements

• Internal and Supplier Audits (US FDA 21 CFR Part 820; ISO 13485; etc.)

• Compliance Gap Assessment

We are also available to consult on and/or help respond to FDA and Notified Body audits for manufacturers and other types of companies.

Book an appointment to chat with our quality assurance consultant now.