Future proof your medtech journey with essential QMS

Ensure regulatory compliance and quality assurance from day one with our tailored and cost-effective QMS packages.

Simplify, Comply and Accelerate: Your QMS Suite

Medtech innovation hinges on establishing a solid foundation for quality management. Quality management is essential for the development of medical technologies and is the process of ensuring that an organisation's products or services consistently meet customer and regulatory requirements through systematic planning, control, and improvement of processes. SOPs (Standard Operating Procedures) are integral to quality management, providing detailed, step-by-step instructions to ensure consistent and compliant execution of tasks within these processes.

Our QMS Suite is designed specifically for early-stage medtech companies, ensuring you start on the right foot with compliant, efficient, and scalable practices.

Our QMS Suite

Essential Start: Starter QMS Package

A streamlined collection of essential SOPs, providing the core documentation needed to implement best practices in quality management from the outset. Our "Essential Start" package offers a curated selection of foundational SOPs crucial for any med tech startup. These SOPs cover the basic regulatory requirements and quality practices, providing a strong platform for growth without overwhelming you with unnecessary complexity.

Full Bang: Entire QMS Suite

A comprehensive set of SOPs compliant with major regulations, including FDA (21 CFR Part 820), ISO 13485, and EU MDR, tailored to support your company's growth and regulatory needs. This package expands on the essentials, offering a full suite of SOPs that address all aspects of quality management in the medtech industry. This package is perfect for companies ready to scale operations and ensure full compliance with international regulations.

Custom Compliance: Your QMS, Personalised

For medtech startups with specific operational or regulatory needs, our "Custom Compliance" service offers tailored SOPs. Whether you need modifications to our existing documents or entirely bespoke SOPs, we work closely with you to align your quality management processes with your unique goals and requirements.

Why Choose Our QMS?

Unlock the full potential of your clinical trials with SOPs that bring decades of world-class expertise right to your doorstep, without the hefty price tag. Here's why choosing our SOP services is the smart move for your organisation:

Cost-Effective Innovation

Bid farewell to the daunting costs of developing SOPs in-house. Our ready-to-implement SOP templates are designed to save you over $30,000, allowing you to allocate your resources where they matter most – in the innovation and development of life-saving treatments.

Plug and Play

Our SOPs are universal and easy to customise to specific Sponsor or trial requirements. They are designed to work together as collections or as standalone documents.

Expertise at Your Fingertips

Developed in collaboration with world-leading experts who have contributed to hundreds of successful trials, our SOPs are the distillation of decades of clinical research wisdom. This means you're not just getting documents; you're leveraging the collective knowledge and best practices of the industry's best.

Unwavering Compliance

With the regulatory landscape constantly evolving, compliance remains a top priority. Our SOPs undergo rigorous reviews to ensure they meet the latest regulatory standards across the UK, US, and Europe. Rest assured, with our SOPs, you're always inspection-ready, no matter where your trials take you.

Choose excellence. Choose efficiency. Choose our SOPs to give your clinical trials the edge they deserve.

How It Works

Firstly, provide us some key information about you so we know how to build your SOPs.
Select the service(s) you’re interested in.
1. If you opt for Precision Picks or Pack & Play, simply choose the SOPs or bundles you need and complete your purchase. Your chosen SOPs will then be securely emailed to you, ready for immediate use.
2. For Tailored Compliance, a member of our dedicated team will contact you within 24 hours to discuss your customisation requirements and the next steps.
A quotation will be sent to you within minutes.
If you’re happy with the quote, simply make payment.
That’s it! For Precision Picks and Pack & Play, we’ll send across the purchased SOPs within the day. For Tailored Compliance for customer SOPs, we’ll be in touch to agree next steps!

Alternatively, if you're simply not sure where to start, but would like a gap analysis of your current SOPs and some guidance on next steps based uniquely on your studies and quality goals, please reach out to us at hello@airclinical.io.

Choose Your Service

FAQs

Our company is conducting trials across varying countries, do I need separate SOPs for each region?

No, you do not. Our SOPs are global in nature, flexible and work in all territories.

We have a small set of SOPs but are not really sure what else we need to ensure we have it all covered?

No problem, one of our experts can work with you to better understand your goals and your starting point. We can help you build the bridge to where you want to be with a complete set of SOPs that ensures your compliance.

Secure Your SOPs