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Posted on: March 26-2018 | By : Sourav Gupta | In: Industries,Life Sciences | No Comments

The journey so far

Year 2017 was a learning phase for the Medical Device industry. With the official launch of the European Medical Device Regulations (EU MDR 2017/745) and European In-Vitro Diagnostic Regulations (EU IVDR 2017/746), many medical device and in-vitro diagnostic companies faced uncertainty and confusion over the new requirements, as well as risks and challenges to their business.

With few exceptions, I have seen most large manufacturers establish a program management (PMO) team and roping in top management consulting companies to help determine the impact on their business and revenues. Small and mid-size companies are working with regulatory consultants to understand the new requirements.

The second half of the last year was mostly spent on awareness sessions, workshops, gap assessment pilots and budget planning. I have spoken to many program directors to understand their strategy, budget and plan for the next two to three years, and led or participated in many knowledge sessions and workgroups. I have learned a great deal so far, and hope to share some of that with you today.

Key Lessons

  1. Simplify program management by creating a 360° view dashboard for each product family. This dashboard should include parameters like revenue, markets, risks, technical files, labels/IFUs, authorized representative, notified body, manufacturing sites, economic operators, QMS, etc., along with your key stakeholders from various functions.

  2. Remove redundancy and organize technical files and design dossiers for each product family in a centralized repository.

  3. Digitize high-value legacy records and technical documents for gap assessment, inspection readiness and easy availability.

  4. Plan ahead for your organization-wide implementation or upgrade to QMS ISO EN 13485:2016, MEDDEV 2.7.1 rev.4, UDI, eIFU Website (Content Management Framework).

  5. Prioritize the remediation of technical files for products with high business impact and complexity.

  6. Evaluate and onboard service providers early in the program to improve the success rate and on-time completion.

  7. Build an agile platform that enables internal and external stakeholders to engage and collaborate on a day-to-day basis.

  8. Implement tools and accelerators to improve visibility, tracking, quality and productivity across workstream projects and your overall program.

Key Lessons

While the industry is waiting for the re-designation of the Notified Bodies, most manufacturers have completed the impact and gap assessment of key technical files and are currently planning for technical file remediation. Keep in mind that if you have a high volume of technical documents, or they are complex, in legacy formats, or not well-controlled or documented under the same product family, remediation will require much more advance planning.

Key considerations for technical file remediation

  • Create/ update SOPs

  • Prepare quality plans for technical files and design history files (DHF)

  • Plan cross-functional work streams for document remediation

  • Identify critical success factors, risks and challenges

  • Develop a detailed checklist to review technical files

Reformatting GHTF
Summary Technical
Documentation (STED)
  • Update formats (GHTF/SG1/N011:2008 for medical devices; GHTF/SG1/N063:2011 for in-vitro diagnostic devices) to align with the new requirements

  • Format documents into paginated and fully searchable PDF files

  • Devise a logical numbering for files (e.g. Part 1 of x, Part 2 of x… Part x of x)

  • Bookmark GHTF STED sections with clear document references

  • Write technical files in an official language of the member state where procedures are carried out, or the language accepted by the Notified Body. English is recommended for all audit-related documents.

  • Use digital signatures or scanned signature pages where signatures are required

  • Make the technical documentation a pointer document

General Safety
and Performance Requirements
  • Update the Essential Requirement Checklist (ERC) and map to the new requirements

  • Mention relevant standards “State of the Art” assessments (fully or partially applied)

  • Provide reference to harmonized standards and justification if not applicable

  • Look for objective evidence to support conformity, linking and bookmarks to relevant documents

Declaration of Conformity
  • Ensure the product list in the technical documentation matches the DOC

  • Sign a new Declaration of Conformity


It requires extremely careful planning and monitoring of different workstreams to successfully remediate technical files. By identifying critical success factors, risks and challenges early on, your planning will be easier and the chances of a “first-time-right” remediation program improve dramatically. By setting-up a digital PMO dashboard, QC checklists, tools and accelerators, you can help ensure a much smoother transition to EU MDR/ IVDR compliance.

Sourav Gupta

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Sourav Gupta
Sourav Gupta has 14+ years of experience supporting the Life Sciences industry in the clinical,...

Posted on: March 12-2018 | By : Imran Sheikh | In: Life Sciences | 1 Comment

Although high-profile data breaches grab the headlines, behind the scenes, life sciences is just as information sensitive as any industry. Any pharma company faces a major challenge when it comes to complying with the myriad regulatory requirements about how they create, handle and submit documentation about the products they manufacture.

Even a minor slip up can have a serious financial impact in the form of fines, penalties, or delayed product launches. With so much at stake, document management is a critical process for any pharma companies.

There are a number of widely-accepted best practices to ensure compliance with regulations, but many of these are extremely complex to implement, meaning that the industry has struggled for years to put them in place. These include:

  • Harmonizing and standardizing all global regulatory submission templates
  • Keeping on top of changing and emerging requirements and timelines
  • Implementing strong versioning and change management practices
  • Maintaining strong governance and process management controls
  • Capturing key performance metrics and feedback from regulatory authorities

At Syntel, our prescription to these challenges is a suite of end-to-end regulatory services, driven by an intelligent regulatory services platform. We combine the power of automation and decades of business process expertise to implement standardized, trusted processes for regulatory operations and submissions to health authorities. We can deliver business outcomes such as:

  • 20% reduction in regulatory writing and submission publishing time
  • Dramatic improvements in submission quality
  • Consistent templates for all clinical documents
  • Easier document lifecycle management

A huge added benefit to more structured and consistent document management is the ability to capture rich metrics at every step in the process. By making the document initiation, preparation and publication process more transparent, we can deliver deep insights into your operations and make continuous process improvement a reality.

If you are ready to take the next step in your document management operations, visit us online at

Imran Sheikh

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Imran Sheikh
Imran Sheikh is Sr. Consultant, Regulatory Affairs at Syntel. He has over 10 years of rich...


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