Regulatory1 is a company started in 2015, Bangalore with the vision of setting up a complete regulatory service for Medical Device and IVD companies

1. Regulatory1
Medical Device and IVD
www.regulatory1.in

2. Introduction
• Regulatory1, is a 4 year old company initiated with the vision of providing complete one stop
solution to startup and mid sized companies. we provide the services from design development till
the product reaches to the market, which includes regulatory requirements, QMS documentation,
testing - electrical, preclinical and clinical and ultimately post marketing activities.
• We have expertise in all the fields, who can provide you support and guidance during the
development. A qualified Lead Auditor with experience working in certifying company for ISO
13485, specialised trained (Ochenhausen, Germany) for Medical Device testing (Electrical,
Biocompatibility, preclinical and clinical studies) are available during the discussion.
•
As a Compliance Certifier, what are the auditors requirement and documents they would like to
see, how the company can pass through the regulatory pathway with all the documents in place
and follow the regulatory requirements are few of the areas where we have expertise and
uniqueness of our company.
• In Regulatory1, we have provided services in terms of ISO documentation, consultation,
implementation, certification support, regulatory submissions for US, CE for European Union -
startup companies and also well established organizations for different class of device and IVD.

3. Services Offered
1. ISO 13485 QMS documentation and certification
2. Internal audit and external audit support
3. Regulatory Dossier - Technical File Preparation
4. CE marking - European Union
5. FDA registration - USFDA
6. Medical Device testing- Safety testing, performance test
7. Product development support
8. Device Design documentation
9. Bio compatibility Studies
10. Regulatory Training
11. Clinical trails
12. Lab Setup as per the GMP requirement (Newly Introduced)

4. Our Products and Services
1. ISO 13485 QMS documentation and certification
2. Internal audit and external audit support
3. Regulatory Dossier - Technical File Preparation
4. CE marking - European Union
5. FDA registration - USFDA
6. Medical Device testing- Safety testing,
performance test
7. Product development support –all Phases
8. Device Design documentation
9. Bio compatibility Studies
10. Regulatory Training
11. Clinical trails
ISO 13485
Documentation and
Certification
Product
Certificati
on - CE
and US
FDA
510(K)
Testing -
Biocompatibility,
Clinical and Preclinical
Training -
Regulatory
Document
ation,
REACH,

5. Key Benefits of Regulatory1 Service
• The key benefits working with Regulatory1
– Early reach to Market
– Smooth path without hurdles
– Training to the team
– Easy access to knowledge
– Guidance as and when required
– Awareness for any issues raise

6. Benefits
• All the Services are professionally handled by team of expertise and
renounce knowledge
• Discussion and up to date guidance and training for your team
• Relieve the stress of multitasking with many department or team

7. Contact Information
Regulatory1
T2, 3rd Floor, Planet Vista, RMV,
Sanjay Nagar, Bangalore- 560094
Tel: +917337811324, +917349611871
www.regulatory1.in