Clinical Evaluation

Benefit-Risk Assessment

Regulatory Strategy

Clinical Strategy

Conformity Assessment Route

Medical Writing

Regulatory Writing

Medical & Science Communication 


BioSciPons bridges the gap between science and people, academia and business, regulatory agencies and manufacturers.

A bridge between two worlds

Regulatory Strategy DevelopmentWe develop regulatory strategies for MedTech and Biotech companies to navigate complex regulations effectively. This involves determining the most efficient path to get products approved by global regulatory bodies such as the FDA (U.S. Food and Drug Administration), Notified Bodies or the EMA (European Medicines Agency).

Submission Preparation: We prepare documentation required for regulatory approvals. This includes drafting and reviewing submissions for premarket approval applications (PMA), 510(k) notifications, and CE marking applications (Clinical and Performance Evaluation Reports). We review the technical file to make sure all red flags are raised and solved before submission to the regulatory authority (e.g., Notified Body).

Compliance Assistance: We help ensure that medical and biotechnology devices comply with the necessary regulatory standards for quality, safety, and efficacy. This involves understanding and applying harmonised standards (EN/IEC/ISO), Good Manufacturing Practices (GMP), and other regulatory compliance requirements.

Keeping Updated with Regulations: We keep you informed about changes and updates in regulatory laws and guidelines across different regions and countries.


Medical Device (MDs) & In vitro Diagnostics (IVDs):

  • Independent Gap Analysis 
  • Clinical Evaluation Reports: writing/editing
  • Clinical Performance Reports: writing/editing
  • Scientific validity report (IVDs)
  • Analytical Performance Reports (IVDs)
  • Benefit-Risk Assessment
  • Technical File: compilation/revision

Regulatory Affairs & Intelligence:

  • Workshops, reports with Global regulations/guidances (e.g, EU, USA, Canada, UK, LATAM, Indo-Pacific)
  • Competitor market analysis
  • Device classification in different global regions
  • Choice of EU Notified Body
  • Conformity assessment procedure
  • Clinical Evaluation Plan
  • Strategy to market

Post-Market Surveillance & Clinical Follow-Up:

  • Post-Market Clinical Follow Up strategy
  • Medical journal manuscripts
  • Choice & Submission to Medical Journal
  • Response to peer-review feedback 
  • Publication support
  • Gap analysis

Medical Affairs:
  • Clinical Strategy: ISO 14155 & Good Clinical Practice
  • User Manual, Instructions-for-Use (IFU)
  • Summary of Safety and Clinical Performance (SSCF)
  • Whitepapers
  • Blogs
  • Press releases
  • Brochures
  • Poster
  • Video scripts

BioSciPons Translating Complex Science to the Real-World

Translating Complex Science into the Real-World.

Bridge the gap between science and people, manufacturers and regulators. 

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BioSciPons: at the interface of regulatory, medical affairs and communication

We are experts at translating complex science into precise and clear communication contents (e.g., Clinical Evaluation Reports, Technical files, Investigator Brochures, Medical Journal Manuscripts, Articles,...). Our aim is to explain the relevance and ramifications of a medical/biotechnology product or biomedical findings, while maintaining regulatory correctness and scientific acumen.

We bridge the gap between medical R&D, regulatory agencies, healthcare and users/consumers - hence our bridge as a logo.

To cross the bridge two things are needed:
  •  A high level of communication and writing skills,
  •  A deep understanding of medical science and regulations. 

As medical scientists and regulatory experts: we understand the complexity of the details. As communicators and journalists: we transform complex clinical data and translate it into a consistent, clear message that is tailored to each target audience (e.g., regulators, notified bodies, medical journal peer-reviewers, board executives, users/consumers/patients).

By using a "Thinking-outside-of-the-box" approach, we foresight the gaps in the clinical data and prepare the product for the "curve ahead". We not only want to cross the bridge, but drive a medical product forward on a straight highway of safety, efficacy and regulatory compliance.

BioSciPons works from any starting point for a customised service.
We personalise our services to fit the needs of each individual medical/biotechnology product.

Customer-specific-made contents tailored to each medical product:

  • Clinical Evaluation Report (CER): medical devices (MDs)
  • Performance Evaluation Reports (PERs): in vitro Diagnostic Devices (IVDs)
  • Summary of Safety and Clinical Performance (SSCP): Health-professional/user & Patient summary
  • State-of-The-Art (SOTA): What is established & What are the trends in the field
  • Clinical Literature Reviews: PRISMA evidence-based Systematic Reviews
  • Clinical Technical reports: Investigator Brochure, Clinical Study Report, Ethics Commission
  • Book chapters/eBooks
  • Whitepapers
  • Press releases

  • Benefit-Risk Assessment: FDA marketing applications
  • FDA 510(K): Equivalence-based, De-Novo, Abbreviated

  • Post-Marketing Clinical Follow-Up (PMCF) gap analysis: Let's find the gaps in clinical evaluation & performance studies

  • Post-Marketing Surveillance Update Report (PSUR): Get your PSUR peer-reviewed & published in a indexed medical journal

  • Instructions-for-Use (IFU): Simplify the language in the user manual
  • Patient-Report Outcomes & Surveys: Which questions matter the most to your patients and users?
  • Scientific Validity Reports: IVDs
  • Analytical Performance Reports: IVDs


  • High-risk medical devices Class III: Cardiac implants, Endovascular stents, Transcatheter implants, Cochlear implants
  • Artificial Intelligence (AI)/Machine-Learning (ML)-enabled Medical Devices: clinical trials, clinical evaluation, documentation
  • Software as Medical Device (SaMD): clinical trials, clinical evaluation, documentation
  • Digital Therapeutics (DTx): clinical trials, clinical evaluation, documentation
  • Telehealth
  • Medical devices with no medical purpose: aesthetics, cosmetics
  • Drug-combination products
  • Biologics
  • Biosimilars
  • Cell & Gene Therapies
  • Advanced Therapy Medical Products (ATMPs)
  • Novel Foods (e.g., cell culture-based meats)


Catarina Carrão (aka Ana Catarina Ribeiro Carrão)

We work with a wide network of PhD scientists in different biomedical fields to personalize each team to the unique needs of a medical product. I, Catarina Carrão, strategise the team according to the needs of the project, budget and timelines.

Previously, I worked in medical academic research for more than 15 years in different international institutions (e.g., Yale University). Throughout the years, I've authored several peer-reviewed medical articles, and was honoured to receive the European Science Slam award - a testimony of my creativity, enthusiasm and ability to communicate science to lay audiences. I'm is able to distill complex scientific ideas in a way that is both informative and entertaining.

In 2006, I was a Marie-Curie Early Stage Researcher (Universitätsmedizin Charité Berlin). In 2011, a Postdoctoral fellow at the Yale Cardiovascular Research Center (YCRC). In 2013, I was honoured Fellow of the American Heart Association (FAHA). In 2012, received the European Science Slammer title. And, in 2021 I was nominated Young Science Journalist of the Year by the Association of British Science Writers (ABSW).

My scientific expertise in neuroscience, cardiovascular, oncology, molecular biology and biostatistics allows me to understand the clinical writing needs of innovative medical devices; and, support manufacturers in navigating the regulatory waters of certification. 

I'm an active delegate of the Regulatory Affairs Professional Society (RAPS), the best way to have the latest insights on the global regulatory affairs landscape. 

In 2022, my work "Creativity in Regulatory Affairs" was selected for the RAPS annual conference. In 2023, I presented "How to use Total Product Life Cycle and Good Machine Learning Practice as your lighthouse when developing and deploying Artificial Intelligence-enabled Medical Devices" at the RAPS Euroconvergence 2023, in Amsterdam. In Eurconvergence 2024 (Berlin) I will talk about "Randomized Clinical Trials vs. Validation Cohort Studies of Artificial Intelligence/Machine Learning-enabled medical devices" and "Effective strategies for high quality clinical data collection through post-market clinical follow-up surveys and medical device registries".

I'm also an accredited science and medical journalist by the World Federation of Science Journalists WFSJ and the Medical Journalist Association MJUK, with several authored articles in different media platforms.

Regulatory Science and policy are my interests, with a wish to see the field moving forward as a way to assess the safety, efficacy, quality, and performance of all medical-related products.

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The first 30 min of consultation are FREE and come with a smile!


Selected customers:

By understanding the importance of writing and wording, not only in written form to peers but also to deliver valuable information to the consumer, BioSciPons is favoured by start-ups, small and medium enterprises (SMEs) in the medical and biotechnology field.

Customer Reviews: