Triumph your success

Your Vision, Your business

Our Expertise

We are dedicated to delivering unparalleded expertise and strategic guidance to business of all sizes across industries.

Krishnaraj Ramaraju
Principal Consultant

Elevating business through our strategic excellence

Welcome to Topothea, your trusted business consultancy partner. Our expertise lies in helping businesses streamline their operations through strategic tech planning. Let us guide you towards achieving efficient and optimized processes for your organization.

MED Tech


We are developing a new technology in Medical Device domain with AI engine and collaborating with various startups to fill the gaps that insdustry leaders left. This will transform the Med Tech domain to accomadate everyone and also make it affordable for everyone

Medical Device Consultaion

For QMS system to regulatory to MDR 


For cybersecurity in Med Tech domain

Our Partnerships

Our Strenght


Med Tech Industry

Regulatory Consultation

Click to download to know more anout our services.

New Product Development Med Tech

Gateway to New Technology

 Lifecycle management for Companies and Startups  developing new Products

USA FDA Regulations

Gateway to New Technology

Looking to launch your existing product into USA?

For US FDA approval and documentations

Eu and EEA

Gateway to New Technology

For new MDR, CE Marking and migration from MDD to MDR


Software as Medical Device

Gateway to New Technology

Developing AI based device or SAMD?

We guide you to the perfect industry standards

Nordic  Experts Welcome Your Business

We understand the challenges and opportunities that businesses face in today's dynamic and competitive landscape. Whether you're a startup looking to establish a strong foundation, an established company seeking to expand its market share, or an organization aiming to optimize its operations, we are here to provide actionable insights and tailored solutions

Our Approach

We believe in a collaborative approach, working closely with you to truly understand your unique goals, challenges, and aspirations.

Our team of experienced consultants brings a diverse range of expertise to the table, ensuring a well-rounded perspective on your business needs.

With a blend of industry insights, data-driven analysis, and creative thinking, we formulate strategies that are not only innovative but also practical and achievable

We Offer

For new business and new market entrants

  Strategic Planning

Crafting a clear roadmap that aligns your business objectives with actionable strategies to drive growth and profitability.

Market Research and Analysis

In-depth market research to identify trends, opportunities, and threats, helping you make informed decisions.

Operational Efficiency:

Streamlining processes and optimizing resource allocation to enhance productivity and reduce costs.

Marketing and Branding

Developing impactful marketing strategies to create a strong brand presence and connect with your target audience.

Financial Advisory

Providing insights into financial management, budgeting, and investment decisions to ensure financial stability and growth.

Change Management

Guiding you through organizational changes, mergers, or expansions, while minimizing disruption and maximizing success.

Technology Integration

Assisting in the adoption of cutting-edge technologies that can elevate your business processes and customer experience

CE Marking

For business looking to enter European Economic Area (EEA)

Regulatory Expertise

We help businesses identify the relevant requirements and standards that their products need to meet.

Product Classification

Classify products into the appropriate categories, determining the type of conformity assessment required and the applicable conformity route

Documentation Preparation

Assist in preparing the necessary technical documentation, including risk assessments, test reports, and other documentation required to demonstrate conformity.

Notified Body Interaction

Guide businesses in selecting an appropriate notified body and managing the interactions with them.

Conformity Assessment Procedures

Assist businesses navigate the various conformity assessment procedures, ensuring that all necessary tests and assessments are conducted correctly

Labeling and Documentation Requirements

Advise on proper labeling requirements and the information that needs to be included with the product, such as the CE marking itself, user manuals, and Declarations of Conformity

Audit and Compliance Review

We offer audit services to review a company's processes, documentation, and procedures to ensure ongoing compliance with CE marking requirements.


Provide training sessions or workshops to educate businesses about CE marking, its importance, and the steps involved.

Updates and Changes

CE marking regulations and standards can change over time. We stay informed about updates and changes, helping businesses stay compliant with the latest requirements.

Market Access Strategy

Provide strategic advice on how to approach market access and expansion into the European market, considering factors such as target countries, product positioning, and compliance timelines.

Cybersecurity Services for SaMD

In today's interconnected world, cybersecurity in the medical device industry is of paramount importance. As business consultants, at Topothea, we understand the critical need to protect sensitive patient information and ensure the smooth functioning of medical devices. Our expertise lies in providing comprehensive cybersecurity solutions tailored specifically for the medical device sector.

With the proliferation of connected devices in healthcare, the risk of cyber threats has increased significantly. Our team of experienced professionals can help your business navigate through this complex landscape by implementing stringent security measures, conducting risk assessments, and developing robust protocols to safeguard against potential breaches. At Topothea, we recognize the unique challenges faced by medical device companies and offer tailored solutions that prioritize patient safety and data privacy. Rest assured, with our support, your business can confidently embrace the benefits of technology while ensuring the utmost protection of sensitive medical information.

At Topothea, we understand the importance of protecting your business from cyber threats. With our expert cybersecurity consultancy services, we provide you with the tools and knowledge to safeguard your sensitive information. Our team of skilled professionals will assess your current security measures, identify vulnerabilities, and develop a customized plan to enhance your defenses. Trust Topothea to keep your business safe in an increasingly interconnected digital world.

With our cybersecurity consultancy service, we offer comprehensive solutions tailored to meet the unique needs of your business. From risk assessment and management to implementing advanced security measures, we ensure that your data remains secure from potential threats. Our experts stay up-to-date with the latest industry trends and technologies, enabling us to provide cutting-edge solutions that safeguard your business against cyber attacks. Partner with Topothea today and let us guide you towards a secure and resilient future.

  • Regulatory Compliance
  • Network Security
  • Information Security
  • Application Security
  • Risk Assessment:
  • Cloud Security
  • Endpoint Security
  • Vulnerability Management
  • Identity and Access Management (IAM)
  • Data Privacy
  • Incident Response and Forensics
  • Security Governance and Risk Management
  • Security Compliance
  • Security Awareness and Training

Nordic Topothea

Why Choose us


Our team consists of seasoned professionals with diverse backgrounds, bringing a wealth of industry knowledge to your business challenges.

Custom Solutions

We understand that every business is unique. Our solutions are tailor-made to suit your specific needs and goals.


We are committed to delivering tangible results. Our strategies are designed to generate measurable improvements in performance and ROI.


Your success is our priority. We maintain open communication and collaboration throughout our engagement, ensuring you're always in the loop