We provide a wide range of Medical Device Consultancy, Regulatory and Quality Services  tailored to meet the specific needs of manufacturers, distributors, and stakeholders in various markets. Our comprehensive services are designed to streamline the product selection and vendor selection process, the regulatory process, minimize compliance risks, and accelerate market access for your medical devices, Biocides and IVD products.

Our services include
Initial Product Search:
Identifying potential products for our customers’ target markets and defining the quality and functional aspects of these products

Vendor Selection:
Identifying possible vendors for targeted products and performing due diligence

Regulatory Assessments:
We conduct thorough assessments to evaluate the regulatory status of these medical devices or IVD products for conformity to the target market. We also assist in developing strategic plans to navigate the regulatory landscape effectively, ensuring compliance with applicable regulations and standards.

Product Registration:
We guide you through the product registration process, including preparing and submitting regulatory submissions to obtain market authorization in target markets.

Quality Management System Implementation:
We help implement robust quality management systems (QMS) tailored to your organization’s needs, ensuring compliance with ISO 13485 or ISO 9001 and other relevant standards.

Commercial assessments:
We also provide negotiating and pricing strategies with potential vendors for products selected taking into account the target market capabilities.

Logistical solutions:
We also provide suitable logistical solutions from vendors to target markets, covering multi modal transport options, including ocean, land and rail based options.

Post-Market Surveillance:
We support post-market surveillance activities, including adverse event reporting, field safety corrective actions, and ongoing monitoring of product performance and safety.

Compliance with UK and EU Regulations:
We help our customers in navigating the complexities of regulatory frameworks in key markets, including the Middle East, EU and the UK. Our consultants stay abreast of the latest regulatory updates and changes, ensuring that our clients remain compliant with applicable regulations and standards. Whether you’re seeking guidance on UK Medical Device Regulations 2002, EU MDR 2017/745, or EU IVDR 2017/746, Roystock Surgical has the expertise and experience to support your regulatory compliance efforts effectively.