Compliance, all simple.
For MedTech & Pharma.

Designed by healthcare regulatory specialists. Easy to use. Covers all local requirements.


We have you covered all the way.

Fast Track to ISO 13485 Compliance

Your path to ISO 13485 compliance starts here. We guide you through the process with a platform that is built for companies like yours. Based on best practices and leading standards.

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We help you to understand what needs to be done.

We help you understand the regulatory requirements and implement them with ease. From documentation and applications to clarification of technical questions, we have you covered.

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Use smart technology to keep your business compliant.

With our user-friendly platform we drastically reduce the effort it takes to comply with regulatory requirements at all times. No more manual, error-prone work that only creates frustration and risks for your business.

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Built for companies like yours

Our software is designed to help businesses like yours simplify the process of obtaining required licenses and registrations and keep them, ensure quality and compliance.


Ensure compliance

Our software helps you comply with all relevant medical & pharma regulations.


Streamline regulatory processes

Our solution automates many regulatory tasks, including document management, change control, and risk management.


Customizable solution

Our software can be tailored to fit your unique needs and integrate with your existing systems.


Save time and resources

Our solution saves you time and resources by automating many regulatory tasks, reducing errors and increasing efficiency.

It is easy. And it is fast.

All our solutions are set up by experts to the highest standards. By automating tasks, the management of the medical & pharma compliance organization becomes easy, effective and fast.

Manage all registrations in one place

Manage all your registrations and licenses in one place while we guide you through the process

Centralize product documentation

Centrally store all product related documentation  and make sure you never miss an expiry date

Easy import & export functionalities

Easily upload existing documentation and export  everything in standard formats when needed

We combine expertise with smart technology

We bring the best expert knowledge to a platform that enables you to meet all regulatory requirements in no time. Benefit from best practices  and year-long industry experience combined with intuitive technology.


What experts say

“Quality is the best business plan. My clients use Playbook to get compliance and quality management out of their way to deliver to the industry. And they save real money”.

Hanlie Olivier
Healthcare Technology Expert

Full Suite of Medical Device & Pharma Compliance Solutions

Licences & Certificates

In order for your business to operate, you must ensure that all required licenses are present in valid form. From the initial submission of an application, through renewals, updates, and payments, the platform supports you with intuitive workflows and tasks.

Central Document Management

Manage all important documents, records, certificates and licenses in one place. Keep regulatory-required records up to date at all times. Ensure certificates no longer expire unnoticed and easily submit updates to authorities.

Quality Management

Playbook is the central platform to ensure quality and compliance for medical & pharma. Rely on an expert ISO 13485-2016 compliance tool, workflows and best-practices which you can customize to your needs with only a few clicks.

In-App Chats

Along with the tasks at hand, communicate directly with others through comments, notifications, and chat functions. Endless email chains and virtual meetings are history. In addition, documentation is assured in the required context.

Modular Roles

Assign roles and tasks to the right people in your organization. Progress, risks, and workload are all visible at a glance. Comprehensive features allow deep insights beyond compliance.

External Experts

Include external expert consultants and let them easily access the platform to assist you. Let the consultants guide you and work together with them towards full compliance - centralized in one place.