About Ninety8 Compliance
We believe compliance should create confidence, not complexity.
Our Purpose
Ninety8 Compliance exists to help organisations operate with confidence. We identify which regulations apply to your products and your business, build the systems that meet them, and keep the evidence that proves it.
We work with organisations where regulatory compliance is not an administrative task but a condition of trading. An inspection, an audit, a marketplace request or a regulator's question has to be answerable on the day it arrives, whether you make the product or bring it in from overseas.
That is why we built Ninety8 Product Compliance, an online app that shows which EU rules apply to each product, collects the documents from your supplier and checks whether they hold up. Behind it is the same expertise we offer directly, for when you want hands-on help.
Why Ninety8 Compliance
Ninety8 Compliance was founded on operational leadership experience — not templates, theory, or generic consulting models.
We bring over two decades of hands-on delivery across regulated manufacturing, medical devices and electronics, building management systems to ISO 9001, ISO 13485 and ISO 37301, and applying the same discipline to EU product compliance.We apply it to the products our clients import too, where the supplier's paperwork often doesn't hold up when someone asks for it.
We are independent. We don't sell testing, certification or representation. We review the evidence, fix what's wrong and tell you where you stand, so our advice is never shaped by what else we're selling you.
Our approach is practical and commercially focused. We help organisations meet their obligations efficiently, without stalling the operation or burying it in documentation it will never use.
At Ninety8 Compliance, compliance is not a barrier to progress. It is what lets you prove you are safe to trade with.
Leadership & Expertise
Ninety8 Compliance is led by Bobby Smith, a regulatory compliance and quality leader with over two decades in regulated manufacturing, and an IRCA Lead Auditor. He holds an MSc (Level 9) in Regulatory Affairs and Process Validation for Medical Devices and is a Chartered Quality Professional (CQI).
His background covers building and maintaining management systems, regulatory compliance programmes, audit readiness and process validation in high-volume, highly automated manufacturing.
At Ninety8 Compliance we apply that discipline across three areas:
- EU product compliance for manufacturers, covering CE marking, CRA, RoHS and WEEE.
- EU import compliance for businesses sourcing products overseas, covering CE, GPSR and PPWR packaging.
- Management systems, built to ISO 9001 and ISO 37301.
Our deepest experience lies in regulated manufacturing, but the principles are the same wherever obligations bind a business. Identify what applies. Build the controls. Hold the evidence. Whether the client is a growing SME, an established manufacturer or an importer bringing products into Europe, the method does not change. Only the obligations do.
If you are facing an audit, an inspection or a regulatory obligation you are not certain you can evidence, we are happy to have an initial conversation.
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