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TIME CRITICAL SERVICES
Regulatory Strategy
From idea to Commercialisation!
Create a pathway to protect your innovation with complete compliance with regulatory requirements.
A well thought regulatory strategy enhances your production, business development and marketing plans.
Representation Services
Regulatory First Responders for your medical device.
We act as your EU AR / PRRC and represent your innovation to the European Commission!
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Market Access
Planning to enter the EU/USA?
Not sure about market entry requirements?
Worried about MDR/USFDA requirements?
We are here for you!
YOUR Regulatory Risk Partners!
We have a list of ongoing and routine services through which we help our clients with complete regulatory compliance.
Check our wide offerings for Medical Devices:
- EU Representation.
- CE Mark.
- USFDA Submissions.
- Define your product and develop your regulatory strategy.
- Liaison with Notified Bodies and Competent Authorities.
- Assessments against new EU Medical Device Regulations to assist with the transition.
- Design control (verification & validation).
- Design file compilation.
- General Safety and Performance Requirements (GSPRs) checklist.
- Risk management analysis (ISO 14971:2019).
- Patient information management (IFU, labelling and Cartons).
- Device classification & predicate device searches (US).
- Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID).
- Cybersecurity and GDPR.
- Sterilisation validation report .
- Clinical Evaluation Reports.
- Investigator's brochure.
- Patient consent.
- Review of summary of pre-clinical data etc.
- Advice, guidance and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems).
- Internal audits, vendor audits, quality and regulatory compliance audits.
- Technical file compilation.
- Submissions/registration management.
- Follow-up meeting to discuss & resolve Q&A form submissions & registrations.
- Adverse events monitoring & reviews including devices undergoing clinical investigation.
- Review & management of product recalls.
Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).
