PS Partnerships Helping Plastics Businesses Navigate Medical Device Regulations

The medical device industry is changing fast, and for plastics companies, that means keeping up with a complex web of global regulatory frameworks and rigorous standards such as ISO 13485, EU MDR and FDA. These regulations and standards are not just red tape, they’re to ensure that materials, processes and finished products are safe, reliable and fit for use in critical healthcare applications.

With over half of all medical devices made from plastic, there is a huge opportunity for businesses across the supply chain to get involved. Whether you’re manufacturing surgical instruments, diagnostic equipment, drug delivery systems or implantable devices, compliance is essential for any manufacturer to demonstrate they meet the stringent requirements demanded by the medical sector.

And the opportunities for the sector are growing at a rapid rate: The global medical devices market size was valued at USD 542.21 billion in 2024 and is projected to grow from USD 572.31 billion in 2025 to USD 886.68 billion by 2032 (Source: https://www.fortunebusinessinsights.com/industry-reports/medical-devices-market-100085)

With the right support, it shouldn’t be difficult to acquire the right certification. And once achieved, it’s a smart move for long-term success.

Why do you need support?

Perhaps you don’t. If you have in-house capability that has a strong grasp of all regulatory requirements, can confirm your products meet the different global medical device regulations, have your ISO certifications in place and can ensure your devices are UKCA or CE Marked for market access, then stop reading now and start organising your staff Christmas lunch. And don’t skimp on the budget.

But if you don’t have in-house capability…

PS Partnerships are here!

PS Partnerships has helped dozens of clients go through every step of the product lifecycle. Whether developing a new device or optimising an existing one, the company help plastics businesses meet regulatory requirements while accelerating innovation and reducing risk.

Services span every stage of development:

• Material Selection & Design Guidance: Ensuring biocompatibility, sterilizability, and mechanical performance
• Quality Management System Implementation: Support for ISO 13485 certification and integration into operations
• Regulatory Compliance & Consultancy: Navigating EU MDR, FDA, and UK MDR with confidence
• Supply Chain Development & De-Risking: Building resilient, traceable, and compliant supply networks
• Product Failure Analysis: Root cause investigations and corrective action planning
• ISO 14971 Risk Management Support & Training: Hazard analysis, risk control strategies, and documentation
• Environmental Impact Reduction: Sustainable materials, recyclability, and lifecycle assessments

You can also rely on PS Partnerships to make sure you remain compliant: UK government has published its response to the consultation on the UK MDR with the aim of improving regulatory scrutiny and oversight of medical devices and In Vitro Diagnostics in the UK. Changes are aimed at closer alignment with international best practice and will ensure that Great Britain has risk proportionate regulations.

PS Partnerships make sure its clients and network have been updated and provided support to meet the changes. Most recently on the new regulations on medical device post-market surveillance requirements that came into force, June 2025.

Your Partner in Innovation

PS Partnerships don’t just consult, it collaborates. Understanding the unique challenges facing plastics companies in the medical and pharma sectors, and tailor the support to fit your goals – technical, regulatory, and commercial.

Some recent projects have covered:

• Implementation of ISO 13485:2016 for a medical device manufacturer to ensure that they can continue to supply to the NHS
• Preparation of technical files for an innovative new medical device that meet the requirements for Europe, Great Britain and the US.
• Breaking into the medical market workshop for a contract manufacturer to understand the requirements, pitfalls and routes to market in the sector
• Bespoke ISO 14971 risk management training for a medical device company, using a number of their products as worked examples.

So, whether you’re launching a breakthrough device, refining a legacy product or looking to break into the market as a contract manufacturer or material supplier PS Partnerships helps you build confidence in your materials, processes, and documentation so you can focus on delivering healthcare solutions that make a real difference.

To find out more about how we can support you, get in touch with Suzanne Johnston at suzanne@ps-partnerships.com or 01743 612050.

Read more news from PS Partnerships here.

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