LIFE SCIENCESMedical / Pharma / IVD
Keep up with the regulatory changes
As one directive becomes obsolete, a new one emerges. Vision Compliance keeps track of every repercussion, every compliance change, and every guideline. Then we suggest possible actions we may take on your behalf. You can rely on our expertise: some of our team members helped draft various regulations governing compliance.
Contact us for a compliance assessment
If you find our advice valuable, we can come to an arrangement to address your needs.
Our services cover
Quick response to our clients’ needs.
Creating regulatory compliance solutions.
One stop shop for placing products on the EU and China market.
Identification and traceabilityClassification of your product in medical, pharma or in-vitro fields.
We can also handle conformity assessment, post-market surveillance, confidentiality, and data protection.
Outsource your regulatory work to Vision Compliance. We can handle it permanently with our expert service and support.
Every industry looking to export to or import from the EU or China must abide by numerous regulations. The applicable regulatory frameworks are constantly changing, so you need professional help to keep track of your compliance obligations.
Competitive pricing and advanced features mean nothing if you encounter chronic problems with public tender procedures in different jurisdictions. Employ our team of experts to alert you to the opportunities and coach you in the correct approaches and processes.
Current Compliance Analysis
Cross-competence expert teams review the state of your product compliance, identify issues, and deliver strategies to resolve them.
EU Market Access Strategy
Develop the optimal regulatory strategy and gain CE Mark certification for devices so that you can freely distribute across EU markets.
Once your products are registered and certified, Vision Compliance assists with operations and sales. We can even help with translations of the product literature the law requires you to include in each product.
Distribution and advertising compliance
We help clients grow through new sales channels, including e-commerce, physical shops, and phone sales. We also assist in expanding audiences through digital marketing and product advertising that’s compliant with EU market regulation.
Notified Body Product Registration Support
Choosing the correct Notified Body for the registration and implementation of your product is critical in the current regulatory environment. Everything moves more efficiently with the right regulatory and medical expert advisors, and Vision Compliance is here to expedite the process for you.
Audits determine regulatory compliance and improve the effectiveness of both your internal processes and your relationships with subcontractors and suppliers.
Vision Compliance can offer test audits, document reviews, practical solutions, checklists and internal audit programs to prepare you for compliance inspections. We can represent you before ministries, inspections, and customs administration officers to avoid delays in your business and sales.
Post Market Activities
European regulation requires medical device manufacturers to consider PMCF as part of their Post Market Surveillance Plan. This makes Post Market Clinical Follow-up crucial for safety and performance throughout a product’s lifetime. Let us organise data gathering and clinical trials on your behalf to ensure safety and compliance.
European Authorized Representative
For manufacturers who are not established in the EU, the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the EU.
Considering the role of authorised representatives, the minimum requirements they should meet should be clearly defined, including the requirement of having available a person who fulfils minimum conditions of qualification which should be similar to those for a manufacturer's person responsible for regulatory compliance
Person Responsible for Regulatory Compliance (PRRC)
According to EU laws every manufacturer should have at least one person with the required expertise in the field of medical devices in their organisation responsible for regulatory compliance.
Micro and small enterprises are not required to have the person responsible for regulatory compliance within their organisation but should have such a person permanently and continuously at their disposal.