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Services

From Strategic planning through quality system implementation, clinical testing, global regulatory registrations and post market surveillance, it is our goal to help you bring and maintain a safe and valuable product to major medical markets around the world.

Client 6

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 endeavours with regulatory demands, optimizing the cost-effective utilization of your company's resources and successfully introducing your products into new global markets.

For example, when addressing the fast-growing field of Software and/or AI-based medical products, we offer comprehensive regulatory mapping and guidance in the desired “go-to markets”, while basing on a total product lifecycle (TPLC) approach and Risk Management route.

Client 4

Regulatory Compliance

Understanding the landscape of the Medical Device and In-vitro Diagnostic Regulations is crucial whether you are seeking FDA clearance, CE, CFDA, Israeli AMAR approval or other regulated markets. Your product 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 regulatory requirements/rules. At BioMedical Strategy, through our in-depth understanding of international regulatory processes 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 activity follows your specific needs, with services including both pre- and post-approval activities:

  • Regulatory Strategy

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

  • Design of specific testing protocols and writing of the reports

    • Bench

    • Ex vivo

    • In vivo animal

    • Clinical

  • Preparation of the submission binder:

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

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

    • Post-Market Surveillance and Clinical activity  

    • Technical File for CE marking

    • Clinical Evaluation , Post Market Plans and Reports

    • Review of software documents

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

  • Leading the submission processes and communicating with the regulatory authorities

Client 1

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/non clinical activities we will support and collaborate in the design of non clinical bench testing and in vivo animal study.

In the clinical field we will provide you with

  • Strategy Development 

  • Generation of a Clinical Investigation Package

    • Design of the Study Protocol  

    • Case Report Forms [CRFs]  

    • Investigator Brochure  

    • Informed Consent & other administrative material  

    • Site & Investigator agreements  

    • Clinical Standard Operating Procedures [SOPs]  

  • Submissions to Ethical Committees & Regulatory Authorities 

  • Clinical Study Conduct and Monitoring

  • Generation of intermediate and final study reports

Client 7

Post Market Surveillance

To maintain compliance with medical regulations requires companies to engage in strong post market surveillance activity. PMS is 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 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 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 build strong and efficient PMS foundations to create a valuable, cost effective compliance system, assuring product quality and safety.

Client 4

Project Management & Developmental Support

Adequate project management strategies are essential and in particular for the successful introduction of innovative medical products into new markets. Effective policies help address regulatory compliance and get faster approvals. Although project management is crucial for the success of any business, it is especially vital for the manufacturers of medical products due to the complex nature of international regulatory authorities and ever-changing requirements. BioMedical Strategy can help develop the right kind of project management matrix while visioning long term goals and building the proper infrastructure to realize them. 

Client 1

Quality Assurance

Companies planning to introduce their medical products to various global markets must adhere to high quality and process control standards. Today’s quality assurance demands from medical product manufacturers are quite challenging. As the ISO 13485 states; manufacturers must be consistently able to meet the quality demands of both the regulatory bodies and clients. At BioMedical Strategy, we design, build and implement quality management systems (QMS) for organizations of all sizes across the Life Sciences industry. Our quality systems consulting experts will work within your organization to create and improve your internal processes, assuring in house understanding of the quality requirements to facilitate the product- to -market process. Together, we guarantee your medical product stays in compliance throughout its lifecycle.

Strategic
Regulatory
clinical
Post Market
Project MNG
QA
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