Medical Device Regulatory Consultant and Facility Design Service Provider.

ISO 13485 Certification Consulting Services:

-Operon Strategist provides ISO13485 consulting service for medical device manufacturers. ISO 13485 is a quality system standard designed for medical device companies. Getting ISO 134485 certification gives manufacturers an upper hand in the competitive market. It is especially beneficial for manufacturers looking to export to Europe as one of the requirements for obtaining CE mark is complying with the ISO 13485 standard. We have guided various clients in USA, Europe, Australia as ISO 13485 consultants.

Benefits of ISO 13485 certification:

Consumer Satisfaction – Production & supply of products that reliably meet consumer requirements as well as quality, safety and legal requirements.

Decreased working costs – through constant change of procedures and improvements in operational efficiencies Better regulatory control & understanding of various components along the supply chain including employees, consumers, vendors, distributors & suppliers

Legal Compliance - regulatory requirements impact the organisation and its customers.

Improved risk management - through more prominent consistency and traceability of items and utilization of risk management technique.

Our services include:

1. Gap analysis of existing system

2. Guidance for documentation as required by ISO 13485

3. Training & implementation

4. Assistance during audit

5. Guidance for complying with audit queries

Contact Details:

Anil Chaudhari

Phone:	+91 (020)46780055
Mobile:	+91 9823283428
Email:	anil@operonstrategist.com
	info@operonstrategist.com
	anilmchaudhari@gmail.com
Website:	www.operonstrategist.com

CE Marking Consulting Services

-Operon Strategist are CE Marking consultant  service providing company for providing CE Marking Service to the clients. Experts are providing legal services on these marks to authorize the marketing scheme in European countries.

-CE Marking Service includes profitable negotiations and clear documentation process. We are providing this service at suitable price.

-The CE marking requirements covers different aspects of a product’s design, production and distribution.

- Regularly, different companies are included in the design , manufacturing , distribution and placing on the market of products.

-The contributions of each single of these links in the production chain and distribution chain may affect the CE compliance of a product.

Contact Us:

operon Strategist
P 511,Mayur Trade Centre,Phase 1 Chichwad Station,Chinchwad,
pune-411019,Maharastra,India 

Website:www.operonstrategist.com  Contact No:tel:+919028043428

#CE #Marking #Consulting #Services:

-#CE #Marking consulting #Services includes:
• Classification of product.
• Selection of suitable conformity assessment route for obtaining CE mark.
• Gap analysis of existing quality system .
• Guidance for implementation of ISO 13485 at the manufacturing unit.
• Guidance for conducting vendor audit.
• Determination of testing requirements as per EU guidelines.
• Determination of labeling requirements as required by EU guidelines.
• Guidance for validation activity.
• Guidance for preparation of technical file.
• Guidance for complying with audit queries.
visit:www.operonstrategist.com
Contact No:+91-9028043428

#Medical #Device #Regulatory #Consultant:

operon strategist are provided Medical Device Regulatory Consultant offered comprises services handled by experienced industry professionals who have with them rich experience as well as in-depth process knowledge to successfully meet the regulatory medical device consultancy requirements. As regulations and requirements vary by country, our experts help clients in gaining deep understanding of applicable regulations and requirements as per the published guidance documents. Some of the features include:Our regulatory experts have specialized knowledge of the many regulatory jurisdictions, including US FDA . Our support ranges widely, including , advisory panel meetings, pre-approval inspections . We frequently consult in emergency situations to resolve warnings, regulatory actions, and handle product recalls.Help clients in negotiating with FDA, EU as well as other international regulatory agencies Our regulatory experts consider information about medical device, including device description and specifications, available test data, literature references.visit:www.operonstrategist.com Contact No: 9823283428