Strategic Planning

In the current era of heightened market competition, it is imperative for your business to engage in strategic planning to gain a competitive edge. At BioMedical Strategy, we understand the importance of crafting a comprehensive and bespoke strategy that anticipates future needs. Our Regulatory & Clinical Affairs expert team proposes close support in identifying pertinent regulatory requirements and devising a compliance program to align with your company's needs, simplifying future challenges and ensuring compliance. By fostering open communication with both companies and regulatory authorities, we develop a strategy that harmonizes scientific endeavors with regulatory demands, optimizing the cost-effective utilization of your company's resources and successfully introducing your products into new global markets.

Regulatory Compliance

Understanding the landscape of the Medical Device and In-vitro Diagnostic Medical Device Regulations is crucial whether you are seeking FDA clearance, CE, NMPA (former CFDA), Israeli AMAR approval, or other regulated markets. Your product's underlying technology, proposed use, medical fields, and target markets define the regulatory path/route, and the specific non-clinical and clinical tasks you are expected to follow when demonstrating compliance with state-of-the-art regulatory requirements/rules. At BioMedical Strategy, through our in-depth understanding of international regulatory processes, consensus standards and vast gained experience, we help you define, build and implement the optimal, most efficient, regulatory pathway towards entering your planned global markets. 

The scope of our activities follows your specific needs for:

• Developing of regulatory strategy and compliance pathways to meet regulatory requirements, through comprehensive design and development process

• While addressing the fast-growing field of software and/or AI-based medical products, comprehensive regulatory mapping and guidance in the desired “go-to markets

• Applying a risk-based approach during the total product lifecycle (TPLC)

• Preparation of the submission binders:

  • Premarket Notifications 510(k)s, Premarket Approvals (PMA)  

  • Q-Submission & Investigational Device Exemptions (IDE`s)   

  • Technical Documentation for CE marking

  • Israeli AMAR submission

• Post-market surveillance (PMS) and post-market clinical follow-up (PMCF) activities

• Interactive working with the company R&D and clinical teams

• Leading the submission processes and communicating with the regulatory authorities

Pre/Non-Clinical & Clinical Activities

Throughout your device developmental process, the pre-clinical and clinical phases can be the most expensive and time consuming yet the most essential for successfully entering planned markets while successfully communicating with the various regulatory authorities. At BioMedical strategy, we are engaged at ensuring a step-by-step coordination between the regulatory authorities and the product developers, already at an early stage, for an easier and more efficient journey to the market while challenged by authorities’ increasing scrutiny. By creating multidisciplinary teams of professionals with product-specific expertise, we ensure building strong foundations for a demonstration of safety and efficacy of your products. 

Whether the intent is to obtain market approval, improve reimbursement, post-market clinical activities or generate publications, our highly qualified team of experts provides dedicated support in all aspects of pre and post market studies.

In the pre/nonclinical field we will support you in:

• Development of compliance pathways for a comprehensive developmental process and least burdensome verification testing plan

• Design, writing or reviewing of specific testing protocols and reports:

  • Bench tests

  • Packaging, shelf-life, environmental tests

  • Analytical performance tests (in-vitro diagnostic medical devices)

  • Ex vivo studies

  • In vivo animal studies

  • Human factors / usability tests and surveys

  • Clinical studies

• Design, writing or reviewing of risk management file:

  • Risk management plan and report

  • FMEA matrix

  • Use-related risk assessment (URRA)

  • Benefit-risk evaluation

  • Risk management review meetings

• Review of software / cybersecurity documents

In the clinical field we will provide you with:

• Clinical strategy development 

• Generation of a Clinical Investigation Package:

  • Design of the study protocol / clinical investigation plan (CIP)  

  • Case Report Forms (CRFs) 

  • Investigator Brochure (IB) 

  • Informed Consent Form (ICF) & other administrative material (submission forms)  

  • Site & Investigator agreements  

  • Clinical Standard Operating Procedures (SOPs) 

• Submissions to Ethical Committees (EC) / Institutional Review Boards (IRB) and Regulatory Authorities 

• Conduct and monitoring of clinical studies

• Generation of intermediate and final clinical study reports (CSRs)

• Scientific review and analysis of clinical data

• Writing of scientific publications such as manuscripts, abstracts, posters, and oral  presentations

• Design and planning of usability (human factors) surveys and testing

PMS / PMCF

Maintaining compliance with medical regulations requires companies to engage in strong post market surveillance activity. Post-market surveillance (PMS) and post-market clinical follow-up (PMCF) are essential not only for providing constant proof for the regulatory authorities that your product can be still claimed as safe and efficient, but also for manufacturers to receive feedback from clinical activity and ensure constant improvements and thereby keeping a competitive edge. In depth understanding of clinical experience with your product provides insight into clinical safety and performance. At BioMedical Strategy, we believe in creating a systematic, proactive PMS/PMCF approach that consists of qualitative and quantitative feedback from users, engaging in industry educational events and keeping up to date with relevant publications. Our team of professionals will support you in building strong and efficient PMS/PMCF foundations to create a valuable, cost-effective compliance system, assuring product quality and safety.

We will support you with:

• Maintaining compliance with the post-market requirements (e.g., MDR (EU) 2017/745 / IVDR (EU) 2017/746, MDCG guidance documents and others) 

• Design, writing or reviewing of PMS /PMCF documents

  • PMS plan and PMS report / Periodical update safety report (PSUR)

  • PMCF plan and report

  • Market validation report

• Providing support in vigilance and medical device reporting activities