Our suite of consulting services covers QMS compliance, technical documentation, product testing, cybersecurity, and human factors engineering to ensure your innovations exceed industry standards. Our In-Country Representation (Sponsor New Zealand and Australia) service ensures smooth regulatory processes, and our Regulatory Monitoring offerings, including Regulatory Radar and Post Market Radar, keep you informed of the latest developments.
Comprehensive Regulatory Consulting Services –
Unlock Your Business Potential with the Johner Institute
Gain the competitive edge your business deserves with regulatory consulting services from Johner Institute New Zealand. Our expertise empowers you to navigate complex regulatory landscapes, ensuring seamless market access and compliance. Leverage our experience to drive growth, enhance product safety, and elevate user experience, ultimately positioning your company for unparalleled success in the medical device, SaMD, and IVD industries.
Rapidly launch innovative medical products, establish QMS, and create lean technical documentation despite limited resources.
Medical Device SMEs
Overcome regulatory challenges, addressing audit deviations, managing capacity constraints, or updating outdated documentation.
Accelerate product development and approval with lean processes, while increasing regulatory compliance.
Market Access Worldwide
Navigating the regulatory landscape can be challenging, especially when entering new markets. At the Johner Institute, we specialize in helping clients achieve market access worldwide by providing guidance and support for regulatory requirements enforced by key regulatory bodies such as the Therapeutic Goods Administration (TGA), the US Food and Drug Administration (FDA), the European Union (EU) Notified Bodies, and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Our expertise includes Australian and New Zealand registration, FDA clearance and approval, and CE marking. With our extensive regulatory experience, we ensure that your products meet the highest standards of safety, performance and quality, allowing you to confidently navigate complex regulatory environments around the world.
Our team of experts understands the importance of a robust and compliant Quality Management System (QMS) in the medical device, SaMD, and IVD industries. We provide comprehensive QMS consulting services tailored to your unique needs, ensuring your organization meets the requirements of international standards such as ISO 13485, ISO 14971, and other applicable regulations. Let us help you establish, maintain, and improve your QMS, guaranteeing ongoing compliance and a competitive edge in the market.
Technical documentation is crucial for demonstrating regulatory compliance and product safety. Our team of specialists assists clients in developing, reviewing, and updating technical documentation in accordance with relevant standards and guidelines. From risk management and usability to clinical evaluation, we ensure your documentation accurately reflects the safety, performance, and effectiveness of your medical devices, SaMD, and IVD medical devices.
To ensure the safety and effectiveness of your products, we offer product testing consulting services, including study design and clinical evaluation support. Our experts help you design and execute robust studies, ensuring they align with regulatory requirements and industry best practices. With our guidance, you’ll be well-equipped to demonstrate product safety, efficacy, and compliance with international standards.
Human Factors Engineering
User experience plays a critical role in the success and safety of medical devices, SaMD, and IVD products. At Johner Institute New Zealand, we provide human factors engineering consulting services to help you understand, identify, and mitigate potential use-related risks. Our experts work closely with your team to incorporate human factors considerations throughout the development process, ensuring your products are safe, effective, and user-friendly.
Software as a Medical Device (SaMD) Consulting
At the Johner Institute, we are experts in SaMD, enabling companies to seize new opportunities and stay ahead in this rapidly evolving field. Our SaMD consulting services are designed to help your organization navigate the complexities of regulatory compliance, risk management, and quality management. With our expertise in cybersecurity consulting, we ensure your products meet the highest standards of safety, performance, and usability. Our experts will collaborate closely with your team, addressing the unique needs and challenges associated with SaMD, offering guidance and support through every stage of the development process and market access journey.
Safeguard your SaMD products from cyber threats with the help of our cybersecurity specialists, ensuring compliance with the latest cybersecurity regulations and best practices.
Quality Management System
Establish and maintain a robust QMS that complies with industry standards and regulatory requirements, such as ISO 13485 and ISO 14971.
Implement effective risk management strategies to identify, assess, and mitigate potential risks associated with your SaMD products.
Adopt best practices in software development to ensure your SaMD products meet regulatory requirements and deliver exceptional performance and safety
In-Country Representation and Sponsorship Services
The Johner Institute New Zealand offers expert in-country representation and sponsorship services for international medical device companies, ensuring compliance with New Zealand and Australian regulatory requirements.
As an Authorized Sponsor for New Zealand and in collaboration with an Authorized Sponsor for Australia, we act as the responsible person for overseas manufacturers. Our expert guidance will help you navigate the local regulatory processes and ensure compliance with each country’s regulatory requirements.
Navigating the regulatory landscape of a foreign market can be challenging. Our team of experts at Johner Institute provides in-country representation services for international MedTech companies, ensuring you have a knowledgeable partner to guide you through the local regulatory process. We stay up-to-date on New Zealand and Australian regulatory requirements and work closely with your team to address any potential compliance issues, facilitating a smooth market entry.
Our sponsorship services include:
Liaising with regulatory authorities on your behalf
Managing product registrations and notifications
Ensuring compliance with post-market surveillance and vigilance requirements
Providing ongoing regulatory support and updates
Let the experts at Johner Institute New Zealand guide your international medical device company through the complexities of the New Zealand and Australian regulatory landscape. Contact us today to learn more about our in-country representation and sponsorship services tailored to your company’s needs.
Stay up-to-date with the dynamic regulatory landscape through the Johner Institute’s efficient and cost-effective regulatory monitoring services for medical devices, SaMD, and IVD. At the Johner Institute, we understand the importance of staying informed in the ever-changing regulatory environment for medical devices, software as a medical device (SaMD), and in-vitro diagnostics (IVD). Our regulatory monitoring services provide affordable and efficient solutions to help your organization stay abreast of the latest developments and maintain compliance.
Our Regulatory Radar service is designed to keep you informed about the latest changes in regulations and industry standards that may affect your business. We monitor the regulatory landscape and provide you with timely updates, ensuring that you have the most current information to make informed decisions and maintain compliance.
Post Market Radar
Our Post Market Radar service focuses on keeping your organization up-to-date with post-market surveillance and vigilance requirements. This service ensures you’re aware of any changes in reporting obligations, incident management, and trending analyses, enabling you to maintain compliance and safeguard the reputation of your products.
Let Johner Institute New Zealand help you stay informed and compliant in the dynamic world of medical device, SaMD, and IVD regulations. Contact us today to learn more about our efficient and cost-effective regulatory monitoring services tailored to your organization’s needs.
Complimentary Resources and Services for MedTech Companies
At the Johner Institute, we offer a comprehensive suite of professional services tailored to meet the diverse needs of our clients in the medical device, SaMD, and IVD industries. While most of our services are fee-based, we recognize the importance of making regulatory expertise accessible to a wider audience. To achieve this, we are proud to offer a selection of complimentary resources that provide valuable insights and guidance in the complex world of medical device regulations.
Informative Blog Articles
Our informative blog articles cover a range of topics related to medical device regulations, industry trends, and best practices. These free resources provide valuable insights and expert advice, enabling you to stay up-to-date with the latest developments in the MedTech industry.
Our Micro Consulting service offers free, brief consultations to address specific regulatory questions or concerns. This service is designed to provide quick insights, guidance, and recommendations to help you make informed decisions and stay compliant.
Our exclusive Starter-Kit is a free resource designed to equip you with essential knowledge and tools as you embark on your regulatory journey. It includes informative guides and checklists to help you navigate the complex regulatory landscape with confidence.
Get Your Free Starter Kit Today!
Get in touch with us to receive your exclusive Starter Kit, your go-to resource for mastering the challenging world of regulations.