One-Stop Shop for Placing Your Medical Devices on the EU Market

We have an exceptional record in preparing submissions for certification of medical devices on the EU market. We offer assistance with preparing technical documentation required for regulatory submissions in the European Union in compliance with EU MDR 2017/745. We assist manufacturers in preparing technical documentation for submission to EU notified bodies and national regulatory authorities to certify their medical devices in compliance with Medical Devices Regulation (EU) 2017/745. Our team has an excellent record in preparing documentation that successfully passes the certification process. Additional services include notification and follow-up with national competent authorities and notified bodies. 


We prepare and deliver technical documentation required for the certification of your devices on the EU market, including the Risk Management File (RMF), Clinical Evaluation (CER), Post-Market Clinical Follow-Up (PMCF), Post-Market Surveillance Plans and Reports (PMS), Periodic Safety Update Reports (PSUR), and Biocompatibility Assessment Reports. We involve a clinical expert in the relevant field as appropriate. 


  • Review, revision, and complete preparation of all parts of technical documentation required for successful certification of medical devices in the European Union 
  • Preparation of Risk Management File in compliance with ISO 14971:2019 and Medical Devices Regulation (EU) 2017/745
  • Screening of scientific literature for Clinical Evaluation Reports (CERs) and Biological Compatibility Assessment Reports (BCARs) 
  • Preparation of Biological Compatibility Assessment Reports (BCARs) in compliance with ISO 10993-1:2018
  • Preparation of clinical documentation, i.e., Clinical Evaluation Plan and Report
  • Design of PMCF studies, preparation of Post-Market Clinical Follow-Up (PMCF) Plan and Report
  • Post-Market Surveillance Plan and Report 
  • Periodic Safety Update Reports 
  • Suggestions for revision of Instructions for Use and other informational materials 
  • Preparation of internal training materials and processes to facilitate the transition to in house follow-up and maintenance 

Our Team has an exceptional record of successful submissions. 

  • Strategy closely coordinated with manufacturers 
  • Experienced team of highly trained professionals 
  • Access to multiple medical specialties 
  • Full-spectrum of required documentation 
  • Attentive and professional staff with a can-do attitude 
  • Extensive knowledge of the regulatory environment

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Research Support in the Pharmaceutical and Medical Device Sectors

We provide custom research to satisfy compliance obligations and support decision-makers in the pharmaceutical and medical device sectors. We cooperate with the Client to define research strategy and objectives to serve business needs. On behalf of our clients, we perform screening of relevant data sources, including scientific literature, and prepare summaries and compile reports for regulatory submission or internal purposes. 


For Device manufacturers, we screen scientific literature and compile summaries to support clinical evaluations, post-market clinical follow-up, and biocompatibility assessments. 


We support literature screening and summaries for PSURs (GVP Module VII), DSUR (ICH E2F), study protocols, and ad hoc background research for the Pharma industry. We provide CONSORT-compliant study summaries, Summary of Findings tables, and grade evidence using Cochrane tools.  


We provide scientific information support for management boards and investors in the life science, medical technology, pharma, and biotech sectors. 

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Training Solutions in the Medical Device and Pharma Sector

We design, develop and implement training solutions based on an analysis of your organization's needs. In collaboration with the Client, we analyze tasks required to perform the job competently, define performance standards, draft curriculum, prepare blueprints for training, and develop training materials and evaluation strategies. We increase organizational resilience by building in-house expertise to make your workforce more agile, efficient, and better prepared to cope with change.



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Operational Risk Management

Full-spectrum multi-service and inter-agency operational plans and policy with proven ability to implement and improve programs through broad-based competencies in 


  • All Source Intelligence Collection Planning, Management, Analysis
  • Analysis determining vulnerabilities of industrial infrastructures and social institutions
  • Decision-Making Process/Analytical Problem Solving
  • Deliberate and Crisis Action Planning
  • Training and Exercise Development/Systems Approach to Training (SAT) and Simulations
  • Special Operations, unconventional warfare (UW), counter-insurgency (COIN), counter-terrorism (CT), Civil-Military Operations (CMO), PSYOPS, Evasion, and Recovery (E&R)

Specialties include mapping and assessment of complex organizational relationships and operational interdependencies to determine potential vulnerabilities in policy, plans, procedures, training, staffing, and job task distribution that directly support organizational effectiveness for competitive agility, business resiliency, and preparedness for continuity of operations.


All organizational dysfunctions track directly to leadership failings (Part 1), (Part 2), (Part 3)

Why plan when you can react?

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